Daniel Haders


Consultant


Biotechnology professional with operations and project management experience supporting biomaterials engineering projects and applications. Multidisciplinary education, research, product management and business development experience in multiple biomaterial groups (ceramics, metals, polymers, liquids) to answer medical needs in orthopedics, ophthalmology and oncology utilizing medical devices and various drug delivery technologies. Highly credentialed Ph.D. experienced in the utilization of virtual development of biomaterials to create new pharmaceutical formulations for treatment of disease for the pharmaceutical industry, including development and support of GMP/USP/EP compliant manufacturing and analytics.

CORE COMPETENCIES

  • Project Management
  • Product/Process Development
  • Design/Development Planning
  • New Product Inception to Production
  • Component Specification
  • Critical Dimensions
  • Test/Analytical Methods
  • Product/Process Transfers/Adaptations
  • New Project Start-ups
  • Material/Bio-Material Specification
  • Supplier Specification
  • Risk Analysis
  • R&D
  • Program/Product Launches
  • Virtual Procurement/Logistics/Operations Feasibility Studies/Implementation
  • Technology Transfer Process Improvement Tools/Statistical Analysis

SELECTED ACCOMPLISHMENTS

  • Managed and/or executed various project activities for nano-drug delivery company including:
    • Initiated, developed and managed corporate operations/infrastructure of accountants, attorneys, consultants and collaborators necessary to launch and run virtual company.
    • Raised seed/angel capital from private investors.
    • Initiated and led search and intellectual property, scientific and market due diligence process to identify technology and patent portfolios for in-licensing.
    • Led negotiations and executed a worldwide license for a patent portfolio from a major US research university.
    • Managed ongoing prosecution of patent portfolio.
    • Developed business and commercialization plans for company and lead product.
    • Developed pre-clinical research and development plan for initial product.
  • • Facilitated, managed and/or executed various project activities for ophthalmic pharmaceutical company developing bio-erodible implant including:
    • Collaborated with a multidisciplinary team including the COO, VP of Preclinical Development, Director of Manufacturing, QA and Regulatory personnel, and numerous academic and contract partners on the formulation, preclinical development, scale-up to clinical GMP manufacturing, regulatory compliance, and business development of product.
    • Designed, directed and managed pre-clinical research and development, contract analytical testing.
    • Designed, directed and managed pre-clinical to clinical scale manufacturing process development. Based on the results of this work a proposal for a process development laboratory at our academic collaborator was authored, which was funded and installed.
  • Facilitated, managed and/or executed various project activities for ophthalmic pharmaceutical company developing nanoparticle suspension including:
    • Collaborated with a multidisciplinary team including the COO, VP of Preclinical Development, Director of Manufacturing, QA and Regulatory personnel, and numerous academic and contract partners on the formulation, preclinical development, GMP manufacturing, regulatory compliance, and business development of product.
    • Designed, directed, and managed research and development, contract analytical testing.
    • Held a primary leadership role in manufacturing scale-up and process development. Work resulted in the proof-of-concept development of a manufacturing process that increased the Phase I clinical trial batch size by at least 2-3 orders of magnitude and was viable for commercial scale manufacturing. Two manufacturing routes were investigated and development work was completed on a budget of less than 25K.
    • Initiated and successfully managed day to day relationships with a CMO & a CAO in a project that aimed to purify and re-qualify a technical grade raw material that is not approved by the FDA for late-stage clinical testing or commercial use, and make that material FDA/GMP compliant. Identified and completed proof of concept testing of a viable processing route as well as developed corresponding analytical testing (USP/EP and equivalents) and product specifications to accomplish task.
    • Researched, identified, developed, negotiated, budgeted, and managed several GMP contract research, manufacturing, packaging, and/or analytical agreements as part of the product’s CMC team. Project team oversaw multi-site Phase I clinical materials manufacturing project, managed multi-facility cold supply chain, and led the research, identification, development, and negotiation of several agreements worth several hundred thousand dollars, which enabled the production of Phase II clinical trial materials
    • Worked in collaboration with senior management on business development projects, participating and in some cases leading the research and development of scientific collaborations, budgets, term sheets, executive commercialization plans, etc.

PROFESSIONAL EXPERIENCE

  • Sanar Biosciences, Co-Founder/President (Edgewater, NJ) – 2010 to Present
  • Lux Biosciences, Senior Scientist/NJCST Fellow (Jersey City, NJ) – 2007 to 2009
  • Rutgers University, Graduate Research Fellow (Piscataway, NJ) – 2002 to 2007
  • I.B.M., Engineer (Yorktown Heights, NY) – 2000 to 2001

EDUCATION

  • Ph.D., Biomedical Engineering and Materials Science and Engineering, Rutgers University, New Brunswick, NJ – 2002 to 2007
  • Recognized Visiting Graduate Student, Department of Materials, Oxford University, Oxford, England – 2005
  • B.S, Biomedical Engineering, Columbia University, New York, NY – 1997 to 2001

TRAINING

  • GMP Regulations and Guidelines, International Pharmaceutical Academy, April 2009
  • Leadership and Strategy in Pharmaceuticals and Biotech, Harvard Business School, Boston, MA – 2009

PUBLICATIONS AND PRESENTATIONS

Patents

  • Riman RE, Burukhin A, Zlotnikov E, Haders D. Hydroxyapatite with Controllable Size and Morphology. United States Patent 7,998,219. Issued August 16th, 2011.

Patent applications

  • Riman RE, Burukhin A, Zlotnikov E, Haders D. Hydroxyapatite with Controllable Size and Morphology. European Patent Application Number – 2005854856.1, Publication Number – EP1846325. Filed December 21st, 2005.
  • Riman RE, Burukhin A, Zlotnikov E, Haders D. Hydroxyapatite with Controllable Size and Morphology. US Patent Application Number – 13/504,143. National Stage Application Filed April 26th, 2012.
  • Riman RE, Burukhin A, Zlotnikov E, Haders D. Hydroxyapatite with Controllable Size and Morphology. European Patent Application Number – 10827398.8-2124. International Application Filed October 26th, 2010

Scientific Publications

  • Haders D.J., Kazanecki C.C., Denhardt D.T., Riman R.E. Crystallographically Engineered, Hydrothermally Crystallized Hydroxyapatite Films: an In-Vitro Study of Bioactivity. Journal of Materials Science: Materials in Medicine 2010 March 16;21(5):1531-1542
  • Haders D.J., Burukhin A, Huang Y, Cockayne D.J.H., Riman R. E. Phase Sequenced Deposition of Calcium Titanate/Hydroxyapatite Films with Controllable Crystallographic Texture onto Ti6Al4V by TEP Regulated Hydrothermal Crystallization. Crystal Growth and Design 2009 Aug 5;9(8):3412-3422.
  • Haders D.J., Burukhin A, Zlotnikov E, Riman R. E. TEP/EDTA Doubly Regulated Hydrothermal Crystallization of Hydroxyapatite Films on Metal Substrates. Chemistry of Materials 2008 Oct 23; 20(22):7177-7187.
  • Haders D.J. Synthesis and Characterization of TEP-EDTA Regulated Bioactive Hydroxyapatite. Ph.D. Dissertation, Rutgers University 2008 May.
  • Haders D.J. Ocular Delivery: New Controlled Release Technologies Broaden Opportunities for Ophthalmic Therapies. Drug Delivery Technology 2008 July/Aug; 8(7):48-53.
  • Shaw TM, Jimerson D, Haders D, Murray CE, Grill A, Edelstein DC, Chidambarrao D. Moisture and Oxygen Uptake in Low k/Copper Interconnect Structures. Advanced Metallization Conference 2003 (AMC 2003), Materials Research Society 2004, 77-84.
  • Ligler FS, Breimer M, Golden JP, Nivens DA, Dodson JP, Green TM, Haders DJ, Sadik OA. Integrating Waveguide Biosensor. Analytical Chemistry 2002 Feb 1;74(3):713-719

Selected Oral Presentations

  • Synthesis and Characterization of a Solution Deposited, Biologically Inspired, Crystallographically Oriented Hydroxyapatite-Bone Interface. D.J. Haders, A. Burukhin, C.C. Kazenecki, E. Zlotnikov, D.T. Denhardt, D.J.H. Cockayne and R.E. Riman. DePuy Orthopaedics-Johnson & Johnson Company, July 19th, 2007, Warsaw, IN.
  • Triethyl Phosphate/EDTA Doubly Regulated Hydrothermal Crystallization of Hydroxyapatite Films on Metal Substrates. D. Haders, A. Burukhin, E. Zlotnikov, Y. Huang, D. J.H. Cockayne, R. E. Riman. American Chemical Society Mid-Atlantic Regional Meeting, May 15th – 18th, 2007. Ursinus College, Collegeville, PA.
  • Deposition of Crystallographically Tunable Hydroxyapatite Films with a CaTiO3 Interfacial Layer onto Ti6Al4V by TEP Regulated Hydrothermal Synthesis. D. Haders, A. Burukhin, Y. Huang, D. J.H. Cockayne, R. E. Riman. Materials Research Society (MRS) Spring 2007 Meeting, April 9th-13th 2007, San Francisco, CA.
  • Deposition of Crystallographically Tunable Hydroxyapatite Films by TEP/EDTA Doubly Regulated Hydrothermal Crystallization for Biomedical Applications. Daniel J. Haders, Alexander Burukhin, Christian Kazanecki, Eugene Zlotnikov, Yizhong Huang, David J.H. Cockayne, David T. Denhardt, Richard E. Riman. 21st Annual Symposium of the Laboratory for Surface Modification, March 2nd, 2007, Rutgers University, Piscataway, NJ.
    • Awarded Best Paper
  • Synthesis and Characterization of a Biologically Inspired, Crystallographically Oriented Hydroxyapatite-Bone Interface. D.J. Haders, A. Burukhin, C.C. Kazenecki, E. Zlotnikov, D.T. Denhardt, D.J.H. Cockayne and R.E. Riman. Schering-Plough Research Institute, March 1st, 2007, Union, NJ.
  • Biologically Inspired, Hydrothermal Crystallization of Hydroxyapatite Films for Biomedical Applications. D. Haders, A. Buruhkin, C. Kazanecki, E. Zlotnikov, Y. Huang, R. E. Riman, D. Denhardt, D. Cockayne. New Jersey Center for Biomaterials. February 8th 2007, Piscataway, NJ.
  • Bioactive Hydroxyapatite Coating for Improved Bone Implant Performance. D. Haders, A. Burukhin, C. Kazanecki, D. Denhardt, R. Riman. First Annual Symposium: Rutgers NSF IGERT on Biointerfaces, October, 20th 2004, Hyatt Regency Hotel, New Brunswick, New Jersey.

Other Publications

  • Logic and Passion: My Path to Entrepreneurship. D.J. Haders. Columnist Biocareers.com. Published July, 2010.
  • Graduate School: A Competence Training Ground. D.J. Haders. Columnist Biocareers.com. Published August 2010.
  • Hydroxyapatite Coating for Improved Bone Implant Performance. Cross Section – The Magazine of Research Across the Disciplines at the Graduate School-New Brunswick, Feature article on cross-disciplinary research and collaboration, Winter 2005.

Philippe R. Hebert


Consultant


Multilingual professional project manager with over 35 years of consulting experience in North America, Latin America, Europe, and Asia focused on supply chain issues with expertise in materials, manufacturing, purchasing, operations, logistics, warehousing, distribution, and regulatory compliance. Highly credentialed with hands-on experience working in medical device, pharmaceutical, telecommunication, aerospace, and defense manufacturing industries. Background in drip/infusion bag, IV set, pain management infusion pump, suction pump, temperature probe, syringe with and without needle, catheter, endotracheal tube, and blood separation (blood transfusion bags, plasma, and platelets) medical device products, and liquid and solid dose drug products.

CORE COMPETENCIES

  • Project Management/Project Plans
  • Project Leadership/Project Facilitation
  • Supply Chain Procurement/Materials Planning
  • Packaging/Transportation/ Logistics
  • Inventory/Warehouse Management
  • Distribution Resource Planning
  • Process Improvement/Six Sigma
  • Lean Manufacturing
  • Kaizen/Kanban/SMED Techniques/5S Methods
  • FDA 21 CFR Parts 820/210/211
  • ISO 9001/FDA Remediation/Gap Analysis
  • Internal/Supplier Auditing
  • Supplier Qualification and Selection
  • Procedural Development/Work Instructions
  • Corrective and Preventative Action (CAPA)
  • Change Management/Change Control

SELECTED ACCOMPLISHMENTS

  • Managed various packaging efforts, including development of packaging specifications, for drugs and other controlled substances in vials, capsules, and caplets (e.g. morphine, profocal, etc.), drip/infusion bags, IV and IV sets of saline, whole blood transfusion bags, plasma, and platelets
  • Coordinated efforts related to packaging changes with various interdepartmental subject matter experts, including R&D, lab, QA/RA, and medical groups
  • Participated in development of packaging related to vibration testing, shock/impact testing, environmental climate control testing, and degradation testing related to pain management infusion pumps and suction pumps, syringes with and without needles, endotracheal tubes, temperature probes, and catheters
  • Reviewed and approved packaging changes for pharmaceutical and medical device products as member of engineering control review boards
  • Developed and implemented Standard Operating Practices (SOP’s) related to procurement, shipping, receiving, and packaging processes for various pharmaceutical and medical device products
  • Relocated facility to Juarez, Mexico generating $5M in annual reoccurring savings
  • Coordinated and facilitated physical move of companies from one location on time and within budget, completing necessary testing and validation of all equipment without issues
  • Implemented same-day pick, pack, and ship process by negotiating discount agreement guaranteeing next-day delivery, which generated $500K in savings
  • Facilitated operational strategies for all supply chain management and transportation for $4.5B holding company with oversight for 133 warehouses, and full accountability for 3rd party services, inventories of $290M, annual issues at $130M and 258K SKUs, $7M freight budget, and corporate investment recovery of $5M
  • Led reengineering of process, production, and performance initiatives related to inbound/outbound freight, purchasing, and inventory control strategies, with reduction of SKUs by 30% through standardization, resulting in $6.1M savings
  • Designed, developed, staffed, and trained new warehouse and distribution facility to be FDA compliant, and resolved all findings based on inspection
  • Implemented SOPs for FDA compliance, staffed, and trained purchasing inventory management group, and generated six-figure annual reoccurring savings through competitive bidding and negotiations, and managed all supplier relationships
  • Performed GAP analysis comparing SOPs and practices to FDA requirements in order to develop plans to ensure compliance
  • Performed internal and supplier audits as lead auditor to ensure compliance with FDA and ISO requirements
  • Implemented lean practices, including 5S, SMED, JIT, Kanban, Kaizen, root cause analysis, process mapping, sales, and operation planning, and trained employees
  • Created, presented, and obtained approval of business plan from executive board
  • Implemented and managed strategies that increased on-time shipments to 90% and decreased back orders by 60%, which halted 5 consecutive years of $2M annual losses
  • Served as CRO and COO for multi-million dollar plastics injection and blow molding company with 60 presses, ranging from 500 tons to 2600 tons, producing household consumer goods
  • Completed situation analysis/reporting for various manufacturing and service organizations, including focused interviews, organizational review and evaluation, analytical analysis of product costs and margins, inventory analysis, customer and supplier analysis and evaluation, sales and operations planning analysis, and continuous quality improvement evaluation
  • Implemented best practices and improved productivity utilizing lean manufacturing practices, as well as benchmarking and KPIs, for plastics molding company
  • Increased machine uptime from 47% to 87% in 3 weeks as result of SMED implementation
  • Implemented 5S and SMED, as well as press-side packing, thereby reducing manpower to machine ratio from 1.87 to 1.4, which in turn generated annualized savings of $350K
  • Served as Plant Manager reorganizing and successfully turning around packaging plant that lost $3.5M each year for 3 successive years and became break-even within 1month
  • Eliminated overtime, implemented lean practices, as well as SMED and 5S, increased machine uptime from 45% to 83%, and reduced scrap from 67% to 32% through Kaizen events
  • Analyzed gross/net profits by product/SKU and developed plan to cull 13 SKUs that represented annual net loss of $1.5M
  • Transitioned spin-off medical device manufacturing company into standalone compliant and functioning entity
  • Worked with private equity firm and board as interim COO to organize, staff, conclude 2 competitors, and assimilate them into 1 viable organization
  • Negotiated and acquired IP rights for two separate and vital manufactured assemblies, saving $250K and $3M, respectively
  • Consolidated two telecommunications divisions generating over $1M in reoccurring savings, increased sales by 60% by refocusing on medical device manufacturing/remanufacturing/repairs, and achieved gross margins an average of 74%
  • Implemented a manufacturing sales forecast and an enterprise budget for medical device
  • Negotiated and signed master distributor agreements with major telecommunication clients providing diversity of products and increasing repair/refurbishment business
  • Restructured manufacturing operation and led major turnaround, growth, and profitability initiative, functioning as GM, to achieve ISO and CE Mark certification, and successfully transition strategies to first tier automotive supplier and medical device manufacturer with net change in excess of $1M
  • Introduced CQI and demand flow technology, including MUDA (waste elimination) and KANBAN, increasing production capacity 60%, reducing scrap 50%, and negotiating freight discounts exceeding $1M annually
  • Assisted $5B manufacturer by managing $19M in inventory, and creating FDA and ISO compliant procedures and work instructions to attain ISO 9001and CE Mark certifications in two Mexico plants and one U.S. distribution center
  • Implemented 90-day strategy, utilizing process mapping and Kaizen events, which decreased back orders by 70%, reduced inventories over $600K, and increased turns from 2 to 6
  • Served as COO for French based operations to consolidate two facilities, generating savings of over $2.5M, and increasing productivity by 38% and annual output by 85%

PROFESSIONAL EXPERIENCE

  • Senex Associates, Managing Partner, Principal Consultant, (Dyer, TN)
  • (Contracted with Mallinckrodt Medical, Nelcore Bennett, Hill Rom, Alcan, SanuWave, Sealtech, Duke Medical University, Kentucky Blood Centers, Dallas Bloods Centers, St. Louis Blood Centers, KCI, Jay medical, Sunrise Medical, PI Medical, Abbott Labs, Hospira, King Technologies, Inc., Synergetics, Focus Management Group, Schrudder Performance Group, Highland Group, ProGuide, and MainPointe) – 4/92 to Present
  • General Public Utilities Corporation, Dir. Materials & Logistics, (Parsippany, NJ) – 9/80 to 5/92
  • General Instruments Corporation, Operations Manager, (Frontsville, MD) – 4/76 to 6/80
  • Control Data Corporation, Materials Manager, (Rockville, MD) – 10/69 to 4/76

EDUCATION

  • Bachelor of Business Administration, Bienville University, Baton Rouge, LA, 1983

CERTIFICATION

  • Certified Professional Materials Manager (PCMM) – 1992
  • Certified Warehouse Manager (CSM) – 1995
  • Certified Lead Auditor, IRCA, (CLA) – 2001

TRAINING

  • Six Sigma, Green Belt
  • Hazardous Material Handling
  • Medical Device Manufacturing FDA Regulations
  • ISO 9001:2000
  • cGMP
  • Root Cause Analysis
  • Demand Flow College
  • Lean Manufacturing Techniques
  • Process Flow Mapping
  • MUDA (Waste Elimination)
  • Gemba (Shop Floor Focus Groups)

AFFILIATIONS

  • Board of Directors, National Industrial Warehouse Managers (NISMA)
  • American Society of Quality (ASQ)
  • International Registry of Certified Auditors (IRCA)
  • Institute for Supply Management
  • Material Handling & Management Society (MHMS)
  • American Production and Inventory Control Society (APICS)

PUBLICATIONS

  • Various publications in Transportation and Distribution (10 Technical Articles), Shipping and Receiving (4Technical Articles), Spectra (3 Technical Articles), Warehousing, Modern Material Handling, EL&P, Inbound Logistics, Material Handling Engineering, WERC, and case studies for Lehigh University (2 Technical Articles)

PRESENTATIONS

  • Various presentations at ASQ for University of North Carolina, University of Georgia, Baltimore Gas & Electric, PECO, and Material Handling Management Society, Toronto

 

Lizauri Hernandez


Consultant


Professional, bilingual consultant with sixteen years of experience in quality compliance, validation and infrastructure systems (Biotechnology, Vaccines and Pharmaceuticals). Broad experiences gained working for pharmaceutical, device and biologics manufacturers.  Background in validation oversight, technology transfer, regulatory documentation, change control procedures, and electronic document management/training systems (delivery and compliance tracking), supporting lyophilized products, injectibles, bacterial and viral vaccines, testosterone gels, small molecule API, solid and liquid formulations.

CORE COMPETENCIES

  • Pharmaceutical Sectors Supported: Small Molecule
  • API, Bacterial and Viral Vaccines, Monoclonal
  • Antibodies/Biotech/OTC (End to End Supply Chain)
  • API Product Development
  • Process Validations (IQ/OQ/PQ)
  • Validation Master Plan
  • Analytical Equipment Validations
  • BAS Qualification
  • Equipment Installation
  • Cleaning and SIP Validation
  • Requalification (Validation Maintenance)
  • Guidelines and Procedures Development
  • Facilities and Utilities Validation
  • Filter Integrity Testing and Validation
  • CCI Validation
  • Regulatory Filings for Bacterial Vaccines
  • Annual Review
  • Product Complaint Investigations
  • Adverse Events Reporting and Investigation
  • Regulatory Agency Inspection Support (EMA, FDA, Health Canada)
  • Consent Decree Management Operations
  • Remediation (Work Plan Implementation)
  • Project Management/Facilitation
  • Statistical Analysis Techniques
  • CAPA Systems (Track Wise)
  • Document Management Systems Administration
  • Training Delivery Systems Administration
  • System Development Life Cycle (SDLC)
  • Risk Management, Analysis and Assessments
  • User Acceptance Testing
  • Document Management Systems
  • Training Tracking and Delivery Systems
  • Training Development and Delivery

SELECTED ACCOMPLISHMENTS

  • Established collaboration with Local Site PMO (LN, LP) and Home Office PMO to facilitate timely completion of consent decree regulatory commitments for Validation Master Plan, Cleaning Validation, Process Validation, Packaging Validation and Computer System Validation CD work plan steps.
  • Provided direct manufacturing site support to ensure consent decree work-plan steps are ready with appropriate documented evidence of execution for company level, corporate level and third party expert confirmations and verifications.
  • Managed CSV and Non-CSV validation interdependencies with manufacturing and facilities QSEs (Quality System Elements).
  • Facilitated the identification and management of interrelated activities to enable the successful completion of Validation Master Plan, Cleaning Validation, Process, Packaging and Computer System Validation procedural and remediation steps.
  • Lead receipt, triage, investigation and tracking of product complaints and assessment for potential recalls.
  • Managed investigations and ensured commitments were delivered by expected deadlines.
  • Managed all facility and related validations associated with Biopharmaceutical Manufacturing facility and related cGMP operations, including:
    • Focused on cleaning validation (assessment and development), utilities, process/facilities equipment, and computer systems and cleaning processes (CIP and COP) using risk assessment methodology.
    • Provided management and oversight of in-house and contracted resources for overall facility startup activities.
    • Provided technical and risk assessment support used in the change management process.
  • Created, implemented and maintained a validation maintenance program for supply chain, biotechnology process, QC Microbiology laboratories, and QC Chemistry laboratories equipment and facilities.
  • Reported progress by implementing quarterly metrics on compliance to scheduled assessments (the implementation of this program enabled the EMA approval of a biologic product).
  • Led design, development, and delivery of education and training solutions in support of Local and Market Level initiatives, including:
    • Ensured that personnel learning expectations around the manufacturing floor operations were met, including performance evaluations and Site Level SOP training.
    • Partnered with business clients and quality organizations to improve human performance and promote compliance.
  • Supported procedural documentation deliverables to organization both internally and globally, leveraging best practices throughout company.
    • Managed Functional Area Representatives (super users) and system improvements by developing user performance, periodic review, and productivity metrics.
    • Reviewed and approved of Change Requests related to a document management system.
  • Lead implementation of quality metrics and communication strategy for use of PharmaDoc (documented periodic review performance was enhanced considerably after implementation).
  • Collaborated with cross-pharma sectors to deliver training (US and Europe) to new super users and facilitate new company on-boarding into the system.
  • Served as member of Quality Validation Harmonization initiative.
    • Lead update, format, and completion of approval cycle for worldwide validation guidance documents.
    • Authored technical guidelines to standardize validation practices among manufacturing sites.
  • Provided technical guidance by developing applications, laboratory scale studies for cleaning and sterilization cycle validation, preparation of protocols, execution of studies, and by issuing the appropriate documentation in order to support atypical investigation and new process implementation, recall management and investigations (management and training of Jr. Engineers).
  • Managed process improvement projects and conducted experiments for filter validation and container closure integrity (CCI) [outcome of experiments used to investigate product packaging issues, to justify CCI combinations (vial, stopper, tubing, sealers) and to identify potential sources of contamination for culture media and bulk vaccine manufacturing processes].
  • Led execution of requalification studies and investigations for cleaning validation and sterilization cycle performance as scheduled (responsible for completion of protocols, final reports and technical memos, and validation documentation revision as part of Bulk Bacterial Vaccine manufacturing facility Pre-approval Inspection).
  • Collaborated in product change over activities for Bulk Manufacturing campaigns (API).
  • Conducted batch record documentation review and collaborated in investigations related to manufacturing issues ultimately used to make determinations for product release or disposition.
  • Implemented Inter-Empleo Computer Software for Department of Labor Employment Services, including:
    • Worked in development and testing of application.
    • Led training development and delivery during new application rollout at client.

PROFESSIONAL EXPERIENCE

  • System One LLC, Liaison for Validation and Process Development (McNeil, Fort Washington, PA) – Dec 2012 to Sep 2014
  • Auxilium Pharmaceuticals, Corporate Compliance Specialist IV (Horsham, PA) – May 2012 to Dec 2012
  • Auxilium Pharmaceuticals, Senior Validation Associate (Horsham, PA) – Nov 2009 to May 2012
  • Merck & Company, Senior Learning Specialist (West Point, PA) – Jan 2009 to Nov 2009
  • Johnson & Johnson, Centocor R&D Senior Specialist Training and Procedural Documentation (Wayne, PA) – Jan 2007 to Jan 2009
  • Johnson &Johnson, Global Biologics Supply Chain, LLC, Validation Engineer II Worldwide Validation Services (Horsham PA) – Aug 2004 to Jan 2007
  • Merck & Company, Senior Engineer Bio/Sterile Validation (West Point, PA) – Jan 2003 to Aug 2004
  • Merck & Company, Staff Engineer Bio/Sterile Validation (West Point, PA) – Mar 2001 to Dec 2002
  • Merck Sharp & Dohme, Engineer Technical Operations (Barceloneta, PR, USA) – Jul 1998 to Mar 2001
  • Deloitte & Touche Consulting Group, Systems Analyst (Hato Rey, PR, USA) – Jan 1998 to Jul 1998

EDUCATION

  • Bachelor of Science, Major in Chemical Engineering, University of Puerto Rico – 1998

TRAINING

  • Passed Engineer in Training (EIT) Exam
  • Risk Management Methodology
  • Principle Centered Leadership
  • Project Management
  • ANOVA (Comparison of Means)
  • Understanding Human Error
  • Planning for Supervisors
  • Building High Performance Teams, Peer Influence
  • Analytical Problem Solving
  • Separation and Purification Techniques
  • Basic Microbiology
  • Container Closure Integrity: Dye Ingress Testing, Headspace (Vials)
  • PRoVOX, Fisher Scientific
  • Safety and Environmental training

Keith Holland


Consultant


Accomplished professional skilled in operations, distribution, supply chain, logistics, production, warehousing, and packaging. Proven record as demonstrated working with global drug manufacturers in the pharmaceutical industry. Extensive background with tablets, liquids, ointments, creams, and aerosols.

CORE COMPETENCIES

  • Project Management/Project Planning Packaging Validations/Material Testing
  • Program Launch/Product Launches Standard Operating Procedures/Work Instructions
  • Product Transfers/Technology Transfers Complaint Handling/Root Cause Analysis
  • Secondary Packaging/Tertiary Packaging Change Controls/Corrective and Preventative Actions
  • Controlled Temperature Shipping Systems 21 CFR Part 211/External/Internal Audits
  • Transportation Testing/Excursions Consent Decree/FDA Remediation
  • Process Development/Process Controls Cost Savings Initiatives/Six Sigma Efforts

SELECTED ACCOMPLISHMENTS

  • Reengineered/managed cold-chain transportation/shipping process, reducing costs $2M (transporting heat-sensitive products was very costly and labor intensive), including:
    • Identified shipping container requirements.
    • Developed protocol for testing.
    • Designed and qualified insulated, protective shipping container pack-outs.
    • Implemented changes across distribution sites.
    • Ensured operational efficiency and product integrity and stability while in-transit.
  • Identified CRT drug transportation/shipping issues, preventing major product losses (temperature extremes facing Controlled Room Temperature (CRT) Rx drugs during shipments from North America to worldwide distribution centers were unknown), including:
    • Conducted Lane Assessment on 98 routes to determine risks to product stability.
    • Concluded 90% of lanes were being exposed to extreme temperatures.
    • Provided corrective guidance.
  • Innovated zone shipping strategy, yielding $3.5M cost/efficiency savings (monthly shipments of promotional literature and Rx samples to 5,500 US sales reps were costly and randomly delivered), including:
    • Developed and implemented zone shipping concept to replace current system.
    • Automated ordering process.
    • Set up four regional zones to provide timely and consistent receipt of monthly/combined shipments.
    • Reduced third party shipping billings 40%.
  • Significantly improved process standardization and audit results (North America distribution centers (DC) had own SOPs making it extremely difficult to establish consistent compliance standards, audit processes, assessments and audit responses), including:
    • Standardized operating processes including safety/environmental compliance, GMP training, cold chain qualifications, and sharing of engineering best practices.
    • Achieved desired compliance consistency.
  • Delivered $3.2M design/build distribution center project on-time/under budget (management vacated existing distribution center (DC) due to increase in sales volume and product growth), including:
    • Sourced and acquired new space.
    • Delivered DC fit-out in nine months with limited engineering support and no impact to customers.
    • Implemented company-first conveyor system, doubling output with 20% less labor.
    • Incorporated safety/ergonomic innovations.
  • Spearheaded packaging facility consolidation and upgrade (served as project lead for packaging operations consolidation project of two separate packaging operations facilities into one upgraded facility as both facilities were old and not up to current GMP standards), including:
    • Balanced day-to-day production objectives/customer service levels against dynamic demands of project.
    • Upgraded GMP facility was more efficient and strategically designed.
  • Saved $125K per incident in rework costs due to line contaminants (current packaging line clearance process was time consuming, often unreliable, resulting in foreign product/component findings during new production runs), including:
    • Promoted team concept approach for performing line clearance inspections, with tasks assigned to packaging personnel and QA inspectors.
    • Reduced foreign findings in three key areas
    • Decreased rework which was significant.
  • Reduced operating costs at growing packaging and manufacturing operation (operations headcount was growing quickly due to increased manufacturing demands and new product approvals), including:
    • Facilitated training, development and guidance of staff and supervisors.
    • Refined operating/manufacturing processes and SOPs.
    • Drove compliance program across two operating areas.
    • Established open, honest and efficient working relationships.
  • Led facilities management for 212,000 sq. ft. distribution center/office environment, including:
    • Volunteered and lobbied management to take on responsibility of all facility management aspects upon opening and fitting out new facility.
    • Established safety program.
    • Sourced, negotiated, and managed all maintenance contracts.
    • Directed capital improvement projects. Ran all aspects of site maintenance program with minimal support staff.
  • Remediated consent decree issues by realigning all aspects of pest control program and cleaning/sanitization program, including third party service agreement, in-house operating SOP’s, training program knowledge assessment, training curriculum requirements, program gap confirmation documentation, gap remediation sourcing, and implementation of all facility-wide. requirements/physical improvements aligned with closing of all audit findings/open CD program gaps.
  • Managed all North America warehouse/distribution facilities in GMP-related compliance initiatives, including driving implementation of sharing of best practices and development of operational SOP’s, providing timely and consistent implementation of packaging technology global initiatives while assuring site compliance.
  • Directed three U.S. distribution centers in all levels of compliance (safety, environmental, and GMP) and regulatory standardization, serving as site facility manager for 212,000 sq. ft. facility, and managing $2.3M budget.
  • Supported 4,500 field force for $1.3B in Rx sales to major wholesalers, chain stores, and specialty pharmacies, including
    • Managed $4.5M budget and cold chain network optimization, cold chain shipping qualifications, small parcel, LTL, air/ocean freight, cargo security, safety/environmental/GMP compliance, third party management, and facilities management, reverse logistics, and hazardous material handling activities at 212,000 sq. ft. site.
    • Worked closely with Customer Service management to ensure emergency shipments were delivered on time- next day, and from most cost effective DC.
    • Dramatically improved delivery times to customers, achieving same-day delivery performance in 80%+ of shipments, substantially improving on typical three-day expectation.
    • Worked closely with department supervisors to ensure competency in operational spending.
    • Supported all new product launches exceeding senior management goals of 24/48 hour launch initiatives.
    • Cross trained hourly personnel across trade, samples and literature functions resulting in 25% reduction in OT spending, and improved same day order picking performance to 75%.
  • Designed and managed $3.2M project for new 212,000 sq. ft. distribution center incorporating high speed conveyor pick/pack application.
  • Managed two separate packaging and manufacturing operations while supporting growing demand for new product, including extensive training and development of new hourly, supervisory, and management personnel, and management of $5.5M operating budget.
  • Managed operations of largest North America distribution center supporting $1B in Rx trade sales, supporting 5,500 sales field forces, introducing “Zone Shipping” program which reduced costs of RX sales rep sample/promotion shipping/ transportation costs by 40%, increasing on-time delivery accuracy from 15-day delivery window to within two days, and increasing operations efficiencies by 35%.
  • Led six-member team of highly motivated professionals in operations/production planning, scheduling, component purchasing for $2B+ packaging and manufacturing operation (involved in NDA submissions and manufacturing/compounding equipment validation).
  • Led automated HiRise warehouse operation team providing just-in-time packaging supplies to three packaging/manufacturing sites, generating stronger commitment from supervisory staff on timely addressing employee concerns resulting in improved morale.
  • Managed compounding/manufacturing and packaging of aerosols and liquids/ointments/cream products, including assurance of on-time delivery performance of finished goods, hosting of site QA and GMP audits, and reconciliation of variances.
  • Improved savings of $400K-750K/year by changing packing operations for tablets, liquids, ointments and creams.

PROFESSIONAL EXPERIENCE

  • McNeil/Gannett Fleming, Inc., Consent Decree QSE Lead (Lancaster, PA) – 2012 to 2013
  • Merck, Inc., Manager Operations North American Logistics – COE (Branchburg, NJ) – 2009 to 20011
  • Schering Plough/Merck, Inc., Senior Manager, Distribution Services (Branchburg, NJ) – 2001 to 2009
  • Schering Plough, Manager, Distribution Center, Supply Chain/Logistics (Branchburg, NJ) – 1998 to 2001
  • Schering Plough, Project Manager Logistics (Branchburg, NJ) – 1997 to 1998
  • Schering Plough, Production Operation Manager (Miami Lakes, FL) – 1996 to 1997
  • Schering Plough, Manager Logistics Operations (Union, NJ) – 1994 to 1996
  • Schering Plough, Plant Support Manager, Production Operations (Kenilworth, NJ) – 1992 to 1994
  • Schering Plough, Manager, Hi-Rise Warehouse Operations (Kenilworth, NJ) – 1991 to 1992
  • Schering Plough, Shift Manager Production Operations (Kenilworth, NJ) – 1989 to 1991
  • Schering Plough, Packing Operations Supervisor (Union, NJ) – 1985 to 1989
  • Schering Plough, Packaging Foreperson (Union, NJ) – 1982 to 1985
  • Schering Plough, In-Process Control QA Specialist (Union, NJ) – 1980 to1982

EDUCATION

  • Bachelor of Arts, Biology, University of Delaware

CERTIFICATION

  • Six-Sigma Green Belt, Raritan Valley Community College, Raritan, NJ – 2009
  • Materials Management Certification, Bloomfield College, Bloomfield, PA – 1994

AFFILIATIONS

  • Pharmaceutical Cold Chain Interest Group (PDA/PCCIG), Pharmaceutical Drug Association

AWARDS

  • Site Energy Star Partner of the Year Award – 2009
  • Schering Plough Safety Operational Excellence Award – 2005 and 2007

James E. (Jim) Ingram, CPP


Consultant


Consulting professional with over 30 years of management experience in packaging, labeling, change control, production engineering, purchasing, and operations. Technical and project management knowledge gained in working with top drug, cosmetic, medical device, and food manufacturers. Background includes pharmaceutical, animal drug, catheter, diagnostic kit, cream and ointment, and supplement products.

CORE COMPETENCIES

  • Project Management/Change Management
  • Product Development
  • Primary Packaging Design
  • Secondary Packaging Design
  • Tertiary Packaging Design
  • Controlled Temperature Shipping
  • Labeling Development
  • Package and Equipment Design
  • Packaging Operations/Process Controls
  • FDA 21 CFR Parts 210/ 211/820
  • Gap Analysis/Impact Assessments
  • Internal Audits/Supplier Audits
  • Change Control
  • Corrective and Preventative Action
  • Root Cause Analysis
  • Failure Investigations
  • Procedural Development
  • Specification Development

SELECTED ACCOMPLISHMENTS

  • Developed primary and secondary packaging for drug manufacturer of respiratory product and liquid API that is ingested requiring special handling and product delivery requirements
  • Completed packaging development tasks for drug manufacturer of new weight loss product, including:
    • Designed primary and secondary packaging, preparing required packaging specifications
    • Created primary material testing protocols
    • Coordinated all distribution testing
  • Managed packaging initiatives for manufacturer of chemo drug, including:
    • Replaced primary packaging material by sourcing pouch material suppliers
    • Developed laminate material for slow release, moisture sensitive product
    • Developed all packaging specifications and test protocols
    • Coordinated outside test lab qualification testing
    • Developed comparability protocol for FDA submission
  • Specified packaging components for manufacturer of new animal drug product, including:
    • Developed primary and secondary packaging specifications
    • Designed special tray package to hold 10 vials with foam protection
    • Designed custom cold pack for delivery of product requiring transport at 2ºC to 8ºC for 72 hours
    • Coordinated cold chain and distribution testing
    • Developed finished labeling artwork
  • Managed various packaging project activities for medical device manufacturer of catheter-based therapeutic products, including:
    • Redesigned primary and secondary packaging to correct ship test failures for surgical kit redesign due to leakage failure during shipping
    • Constructed samples for testing
    • Developed new packaging specifications for all levels of packaging
    • Facilitated packaging line trials in house
    • Coordinated distribution analysis testing at outside lab
  • Led numerous project efforts for medical device manufacturer of test kit for HIV testing, including:
    • Conducted field testing of kits
    • Sourced components for all primary and secondary parts
    • Coordinated all container/closure testing
    • Coordinated distribution analysis testing, including environment controls
  • Led labeling/packaging transfer for drug manufacturer of Rx solid dose products, including:
    • Facilitated technology transfer and site evaluations during merger of two companies
    • Managed packaging/labeling team for all product integration
    • Invented and internationally patented tablet recovery system generating profit and savings in excess of $2,000,000 per year
    • Received award for six-month early launch of tablets to help control HIV infection
  • Performed engineering function for manufacturer of cosmetic products, including:
    • Managed all package and equipment design
    • Sponsored value analysis/cost reduction program resulting in five-year total savings of $10,000,000 in packaging/process changes
    • Acted as team leader on MRP II implementation program
    • Served as manufacturing site representative for all marketing teams for new and improved product launches
    • Conducted site meetings and maintained project schedules and budgets for all product launches and extensions
    • Conducted line trials and test production runs in packaging and manufacturing in conjunction with Marketing and Product Development
  • Led and managed change control operations for drug manufacturer of consumer healthcare, vaccine, and prescription medication products, including:
    • Directed cross-functional team that developed new comprehensive change control process
    • Implemented centralized change control process for U.S. and Canadian operations
    • Managed on-time processing, accuracy, and compliance of all changes that impacted products produced and distributed in U.S. and ROW market (process times reduced to no more than 14 days)
    • Served as U.S. representative for all world-wide change control activities and led two international workshops
    • Established as point of contact for change control and process deviation issues during FDA audits and inspections and conducted numerous successful audits
    • Provided expert recommendations and consultation to local and global product development teams, technical working parties, new product scale-up teams, and new product pre-approval matrix teams
    • Led and assisted in audits of critical contract and component/raw material suppliers
    • Managed investigations of product/process deviations, exceptions, and complaints to determine root causes and corrective actions
  • Managed variety of purchasing activities for drug manufacturer of pharmaceutical products, including:
    • Managed performance of buyers and other purchasing specialists
    • Negotiated contracts for capital purchases of equipment and MRO/operating supplies
    • Provided support to all engineering functions in preparation of confidentiality disclosure agreements and patent submissions
    • Established contracts program for qualified suppliers of goods and services insuring compliance with cGMP requirements and hazard communications, and developed and implemented policies and procedures
    • Developed and implemented methods for cost savings reduction for supplies and equipment resulting in millions of dollars in savings per year
    • Led team of inter-company associates and local town officials in successful pursuit of natural gas services to facility, resulting in utility cost savings
    • Led supplier certification program and established criteria for qualifications
  • Managed construction and startup of 70,000 sq. ft. particleboard laminating facility for chemical process plant, including:
    • Developed specifications, negotiated, and purchased plant equipment from Europe
    • Coordinated complete plant start-up on schedule with $10 MM budget, specifically project feasibility, incorporation, accounting systems, personnel hiring, sales and marketing assistance, technology transfer, building construction, equipment installation, raw material sourcing, contract negotiations, training and start-up, environmental and safety compliance, and hazard communication program
  • Completed construction and start-up of 400,000 sq. ft. modern snack food bakery for food manufacturer, including:
    • Managed operations with $45,000,000 budget for two facilities with total employment of 1000 union associates
    • Developed successful plan for existing facility closing and equipment relocation operations to new facility
    • Developed and implemented cost reduction and policy/procedure programs for cGMP compliance
    • Completed implementation of MRP II program, preventive maintenance management program, and business resource planning
  • Provided national seminar and training classes in areas of packaging and labeling, change control, compliance, complying with SUPAC, CAPA, FDA systems-based inspection, quality systems, cGMP compliance, risk management, internal auditing/supplier auditing, clinical supplier auditing, and investigations

PROFESSIONAL EXPERIENCE

  • Ingram Consulting Services, Inc., Consultant (Angier, NC)
  • (Contracted with Pharmaceutical Training Institute, PharmaDirections, Inc., Teva Pharma,
  • Arrow International, Medicis Pharmaceutical, Merck, Sandoz, Novartis, Cangene, Neurotech Inc., APlus Secure Packaging, BioNet Pharmaceutical Center of NC, GMSI, and Tunnell) – 2001 to Present
  • Glaxo Smith Kline, Inc., Change Control Mgr. (Zebulon, NC) – 1998 to 2001
  • Glaxo Wellcome, Inc., Principal Production Engineer (Zebulon, NC) – 1997 to 1998
  • Glaxo, Inc., Sr. Buyer Purchasing (Zebulon, NC) – 1992 to 1997
  • GVK America, Inc., Plant Operations Manager (Biscoe, NC) – 1990 to 1992
  • Bahlsen, Inc., Plant Manager (Cary, NC) – 1986 to 1990
  • Almay, Inc., Senior Manager of Engineering (Oxford, NC) – 1979 to 1986

EDUCATION

  • Associates Degree, Engineering Sciences, Central Carolina Technical College, Sanford, NC – 1973
  • Work towards B.S, Campbell University, Buies Creek, NC

CERTIFICATION

  • Certified Packaging Professional (CPP), Institute of Packaging Professionals – 2007

AFFILIATIONS

  • Member of Consultants Council for Institute of Packaging Professionals (IOPP)
  • Chairman of Board of Directors of Consultants Council of IOPP
  • American Institute of Plant Engineers (AIPE)
  • Institute of Industrial Engineers (IIE)
  • National Association of Purchasing Managers (NAPM)
  • Institute of Packaging Professionals (IOPP)
  • Member of College of Fellows for IOPP
  • Board of Directors for Wake Technical College Foundation
  • Board of Directors for Native American Health Education Fund
  • Institute of Packaging Professionals Consultant’s Council

PUBLICATIONS

  • “Capital Justification Process”, Packaging Digest
  • “Daily Supplier Report Card”, Pharmaceutical & Medical Packaging News
  • “Maintaining Production During Expansion”, Food and Drug Packaging

PATENTS

  • Patent #5,442,892 Tablet Recovery System

Bikram Kamboj, RABQSA


Consultant


Professional consultant having executive experience, with expertise as lead or principle certified auditor responsible for audit planning, scheduling, conducting, and reporting for numerous ISO 9001, ISO 14001, ISO 13485, and OHSAS 18001 management systems. Highly credentialed with over 10 years of hands-on auditing experience working with medical device manufacturers, including process validation and equivalency studies for process risk assessment according to ISO 14971. Background in general medical and dental implants, quick brain drills, orthopedic tools (reamers, taps, and quick drills), and heart pump implants.

CORE COMPETENCIES

  • Precertification Audits ISO 13485
  • ISO Audits ISO 14971
  • Gap Analysis ISO 9000
  • Internal Audits Council Directive 93/42/EEC (MDD)
  • External/Supplier Audits Directive 98/79/EC (IVDD)
  • Product/Process Audits Directive 90/385/EEC (AIMD)
  • Design History File Audits SOR/98-282
  • Technical File Review ISO 14001
  • 510 (K) Review OHSAS 18001
  • Design Dossier Review Quality Management Systems
  • 21 CFR Part 820 Regulatory/Quality/Compliance Management

SELECTED ACCOMPLISHMENTS

  • Conducted ISO and OHSAS audits for many medical device manufacturers to include audit planning, scheduling, and reporting related to ISO 9001, ISO 13485, ISO 14001, and OHSAS 18001
  • Maintained and implemented latest regulation changes, as well as updates for any ISO/OHSAS, or environmental management systems for clients as lead consultant
  • Maintained quality management systems for numerous manufacturing companies in the medical device industry
  • Consulted with many medical device/equipment companies to ensure that proper process validation and equivalency studies in place for process risk assessment according to ISO 14971
  • Audited various clients as a subcontractor auditor for certifying bodies, including Global Registrar’s, The Registrar Company, BSI, and TUV for ISO 9001, ISO 13485, and ISO 14001
  • Performed regulatory audits for products per European Medical Device Directives (AIMD, MDD, AND IVDD), FDA, and CMDCAS as requirements
  • Completed 510 (K) FDA file reviews, design dossier reviews (EU Directive), and technical file reviews (EU Directive)

PROFESSIONAL EXPERIENCE

  • Global ISO Auditing, Founder, Lead Auditor, January 2003 – Present
  • Richter Precision Inc., Corporate Quality and Safety Manager, May 2007 – Present
  • Amino North American Corporation, Plant Manager, June 2002 – May 2007
  • General Motors, Supplier Quality Engineer, June 2000 – June 2002

EDUCATION

  • BS, Industrial Production Engineering, University of Mysore, 1995

CERTIFICATION

  • RABQSA Certified Internal Lead Auditor, TS 16949
  • RABQSA Certified 3rd Party Lead Auditor for Quality Management System, Scope ISO 9001/ISO 13485
  • RABQSA Certified 3rd Party Lead Auditor for Environmental Management System, Scope ISO 14001/EMS Compliance/Environmental Planning
  • RABQSA Certified 3rd Party Principle Auditor for Occupational Health and Safety, OHSAS 18001
  • Licensed Professional Engineer, Ontario Canada

TRAINING

  • Corrective and Preventive Action, Chrysler Supplier Development
  • APQP, General Motors University
  • PAPP, General Motors University
  • Certified Lead Auditor, 2nd Party, ISO 13485:2003
  • General Industry Safety and Health, Labor Department
  • RABQSA Competency for OHSAS 18001

Elaine Kindell


Consultant


Effective leader with successful reputation for heading Quality System, Compliance, R&D, and Quality Operations organizations in global medical device businesses. Proven ability to develop, maintain and improve quality systems and processes, data governance, team building, collaboration and change management. Background in global medical devices, including In-Vitro Diagnostic consumables, instruments, software, and orthopedic implants.

CORE COMPETENCIES

  • Design Controls/Design Changes/DHF
  • Risk Management/FMEA/Hazard Analysis
  • Design & Process FMEA
  • Process Validations (IQ/OQ/PQ)
  • Production & Process Controls
  • Mfg. Procedures/Work Instructions
  • Line Clearance and Inspection Procedures
  • Nonconforming Product
  • Corrective & Preventive Action
  • Project Management/Leadership/Facilitation
  • Change Management/Process Upgrades
  • Quality Plans/Project Plans
  • Product Recalls/Adverse Event Reporting
  • Quality Assurance/Quality Control
  • Quality System Requirements
  • FDA Inspection/Remediation
  • Internal & External Audits/Gap Analysis
  • Quality Management/Compliance Management
  • 21 CFR Parts 803/806/810/820
  • ISO 9001/ISO 13485/ISO 14971
  • Council Directive 93/42/EEC
  • Canadian Regulations/SOR/98-282

SELECTED ACCOMPLISHMENTS

  • Provided on-site and remote support for Class I medical device manufacturer to ensure compliance with FDA 21 CFR Part 820, ISO 13485 and corporate procedures; successfully secured contract as a new supplier for a large medical device company, including:
    • Reviewed and approved process validation protocols and reports.
    • Assisted with development of CAPA responses.
    • Upgraded processes, including site Quality Manual, document control, sampling plans, training, pFMEA, DHR’s, and DMR’s.
    • Trained associates on proper product handling and GDP documentation.
  • Maintained ISO 13485 and IVDD certificates for multiple Class II diagnostics sites, including:
    • Managed re-certifications.
    • Led FDA QSIT and BIMO inspections at both US and European facilities.
    • Implemented harmonized electronic complaint handling system and management review process.
    • Implemented corrections and removals for multiple product lines; managed responses to FDA; no related FDA inspections occurred.
    • Successfully managed $1.5 MM budget and staff of 30 global personnel.
    • Developed and implemented internal training for corrective and preventive actions and validation.
    • Upgraded MDR process to improve documentation consistency and reduce turn-around time.
    • Led team responsible for response to 483 Observations and Warning Letter.
  • Responsible for compliance activities across multiple sites, including:
    • Led decision making process concerning product performance issues and ensured appropriate investigation, documentation, and internal and external notifications.
    • Ensured timely and appropriate responses to 3rd party inspection observations, adverse event reporting, and complaint handling activities.
  • Served as QS Management Representative for multiple IVDD business units, including:
    • Provided leadership and support as primary contact for 3rd party inspections.
    • Led cross-functional team to harmonize electronic system complaint handling systems used across multiple business units (SAP P40, GSMS, etc.).
    • Led continuous improvement event to decrease response time for customer communication of Field Actions.
    • Prepared and presented Management Review, Quarterly Business Review, and other Quality System reports as requested.
  • Led the Global Technology Management Council to provide aligned leadership and support R&D development activities across four IVD businesses, including:
    • Served as Quality representative for hardware and software product development teams to ensure compliance with applicable regulations (including software for in-vitro diagnostic instruments Dimension, Vista, and Stratus CS).
    • Upgraded stage-gate new product development process including training of all affected personnel.
    • Facilitated Product Approval Committee and the Product Strategy Team meetings and multiple product development teams.
    • Initiated processes improvement including a Project Tracking Database, consolidated project priority list and streamlined decision documentation.
    • Developed R&D Quality Plan and managed multiple improvement initiatives.
  • Successfully led various organizations through initial ISO registrations, upgrades and assessments to new and revised international standards, including:
    • Implemented Quality System compliant with FDA Quality System Regulation (cGMP), ISO 9001, and MDD.
    • Led organization through ISO registration and CE marking for devices including preparation of Technical Files.
    • Achieved business-wide ISO 9000 registration through coordination of multiple functional groups within diagnostics business.
    • Submitted US Pre-market Notification (510k) for advanced technology digital capture device for use in general projection radiography and submissions for approval in Japan and Canada.
    • Provided regulatory guidance to Product Development teams.
    • Developed and implemented supplier certification program.

PROFESSIONAL EXPERIENCE

  • Quality Solutions Now (QSN), Consultant, 6/15 to 12/15
  • DePuy Synthes (Johnson & Johnson), Director Supply Chain Compliance, 3/13 to 7/1
  • Siemens Healthcare Diagnostics, VP Quality Systems and Compliance – 3/10 to 12/12
  • Siemens Healthcare Diagnostics, Sr. Director Quality Systems and Compliance – 11/07 to 2/10
  • Siemens Healthcare Diagnostics, Director Quality Systems and Compliance – 4/05 to 10/07
  • Siemens Healthcare Diagnostics, Director Technology Management – 9/02 to 3/05
  • Sterling Diagnostic Imaging/Direct Radiography, Reg. Affairs and Compliance Mgr. – 12/95 to 10/99
  • DuPont, Quality Systems Engineer – 2/81 to 11/95

EDUCATION

  • Master’s Business Administration, Southern Illinois University, Edwardsville, IL, 12/86
  • B.S. Civil Engineering, University of Delaware, Newark, DE, 12/80

CERTIFICATION

  • Project Management Certificate, University of Delaware – 06/04
  • Certified Quality Auditor (CQA), American Society of Quality – 06/95 to Present
  • Certified Quality Engineer (CQE), American Society of Quality – 06/84 to Present

TRAINING

  • Lead Auditor Training for ISO 13485, Oriel Stat-A-Matrix, 04/13 (5.5 CEU’s)
  • Quality System Requirements and Industry Practice, AAMI, 10/13 (3.2 CEU’s)
  • Medical Device Quality Enhancement, McKinsey & Company, 8/11 (.5 CEU’s)

AFFILIATIONS

  • American Society of Quality (ASQ) (Member #60131) – 04/85 to Present

John T. LoPiccolo


Consultant


Professional with years of Project Management, Operations, Compliance, and Validation experience within major Pharmaceutical, Consumer Products and Biologics Manufacturers with demonstrated year-over-year improvements in quality, cost and delivery functions.  Broad experience as a strong, ethical, approachable, decisive leader, with excellent analytical, organizational, team building and planning skills. Consultant with effective technical and communications skills, displaying an uncompromised focus on high quality and production improvement. Background successfully managing multiple Consent Decrees, 3 cGMP/Quality and Operations Remediation Projects through Certification as Site Project/Program Manager responsible for Equipment, Process and Cleaning Validation/Qualification Projects for Oral Solids, Liquids and Biologics Operations.

CORE COMPETENCIES

  • Project/Program Management
  • Strategic Leadership and Planning
  • Microsoft Office/Microsoft Project
  • Trackwise Electronic Systems
  • Kaizen/5s/Lean Manufacturing
  • CAPA/Deviations/Investigations
  • Quality Systems/Quality Auditing
  • Technology Transfers
  • cGMP Compliance/Remediation
  • Process Improvement/Quality Improvement
  • Operating Procedures/Work Instructions
  • Training/Training Materials/Assessments
  • FDA 21CFR Parts 3/4/11/210/211/803/820
  • Packaging/Warehouse/Distribution Operations
  • Validation Management/IQ/OQ/PQ
  • Supply Chain Operations

SELECTED ACCOMPLISHMENTS

  • Managed projects as Implementation Specialist that interfaced with multiple organizations both internally and with external partners, including:
    • Ensured alignment, prioritization and maintenance to schedule.
    • Managed technology transfer of diagnostic test kit.
  • Managed  project for bio-sterile validation for major pharmaceutical manufacturer, including:
    • Developed and maintained project schedules for department engineering projects.
    • Reviewed/edited validation protocols for technical and compliance requirements.
    • Managed/participated in validation protocol upgrading project and product extension validation (clean room experience).
    • Managed resources (25 engineering validation consultants).
    • Managed $3mm validation project.
    • Oversaw and negotiated change orders as required and new project proposals.
    • Set-up and lead weekly departmental project scheduling meetings.
    • Proactively monitored and reported progress to the department’s Associate Director and Project Team against project plan to ensure deliverables were on time and costs were within budget.
  • Managed supply chain that supplied specific demands for assigned clinical trials as global clinical supplies project manager, including:
    • Negotiated with internal supply chain groups: Clinical Manufacturing, Packaging, Regulatory Affairs, Contract Research Organization outsourcing, and PharmSci Quality.
    • Maintained close communication with appropriate ‘customers’ representative regarding international requirements, clinical study forecasts, timelines, resource capacity constraints, and drug supply.
  • Project managed quality/compliance for technology transfer on new Science Center for start-up Bio-Tech Clinical Phase 1 to 4 contract manufacturer, ensuring that all projects met timeline and adhered to GxP requirements, including clean room requirements.
    • Helped design, draft and implement GxP training program, safety training program, preventative maintenance program, and waste stream management program.
    • Drafted operating procedures for: water for injection (WFI), clean steam system, unidirectional airflow systems and pre-treatment water system.
    • Drafted qualification document for unidirectional airflow systems.
    • Help design vial/syringe inspection and packaging program.
    • Facilitated and managed clients’ products/projects through facility and technology transfer.
    • Compliance/quality reviewed, edited, and approved all engineering qualification documents for site.
    • Drafted qualification document summary reports and project time lines.
  • Developed and managed remediation project plan to meet new regulations for combination products as Senior Project Manager, including:
    • Identified and analyzed issues affecting project.
    • Monitored ongoing progress of key deliverables against plan goals, including identification of potential risks and contingency plans.
    • Mentored team members in compliance remediation.
    • Communicated progress of project deliverables to teams and Senior Management.
    • Conducted CAPA Tracking and review.
  • Developed and managed required major process steps toward consent decree remediation deliverables concurrence for Warehousing, Distributions, Shipping, and SAP and Materials/Components As Senior Project Manager, including:
    • Managed 34 projects and approximately 100 project team members across 2 solids and liquids manufacturing sites, utilizing process excellence tools.
    • Developed, enhanced, and implemented mechanisms to track and report on remediation work plan progress
    • Managed gap analysis and remediation of procedures and standards to regulatory findings.
    • Facilitated and drove teams based upon accountability to achieve robust and sustainable processes.
    • Managed project plan development and management with project status updates and progress reporting for 2 manufacturing sites.
    • Drove cross-functional teams to resolve issues.
    • Conducted “As-Is” and “To-Be” Process mapping.
    • Managed auditing of new processes for sustainability.
    • Identified and analyzed issues affecting project.
    • Facilitated achievement of goals for project plan.
    • Monitored ongoing progress of key deliverables against plan goals, including identification of potential risks and contingency plans.
    • Communicated progress of project to teams and Senior Management.
    • Mentored team members in compliance remediation.
    • Project/program managed certification re-start (Warehousing, Distribution, SAP and Materials/Components) on new liquid production facility.
  • Acted as single point of contact for all technical and quality-related activities at external supplier as external supplier/site auditor, including:
    • Audited processes to ensure cGMPs were properly executed for combination products, medical devices, and liquid biologics.
    • Managed all manufacturing investigations and CAPA reviews.
  • Identified/reviewed/edited quality systems and procedures and remediated to current FDA 21CFR Parts 111/210/211 and EU Part II for quality systems and manufacturing, packaging operations, and compliance remediation, including:
    • Mentored in Quality Compliance, as change agent in Quality, Packaging, Manufacturing, Facilities and Warehouse operations.
    • Conducted supplier quality audits.
    • Remediated deviation/investigations, CAPA, audit tracking, GDP, facilities and ERP systems SOP’s.
    • Acted as interim site quality manager/lead at pharmaceutical manufacturer (developer and manufacturer of liquid filled capsules).
    • Participated and helped manage regulatory agency audits.
  • Managed $15MM consent decree validation/compliance project for new and legacy equipment, utilities, and computer systems within Packaging/Manufacturing areas, including:
    • Managed technical transfer of packaging line.
    • Managed CAPA and customer complaint investigations associated with packaging operations.
  • Project managed packaging and labeling of liquid and lyophilized products, syringes, and DEA CII liquid and solid dosages pharmaceuticals.

PROFESSIONAL EXPERIENCE

  • Acro Staffing Inc., Contract Implementation Specialist, (Livonia, MI) – January to March 2016
  • Otsuka Pharmaceuticals, Contract Ext. Suppl./CMO Auditor (Princeton, NJ) – July 2014 to March 2016
  • Atrium Innovations, Contract Senior Consultant (Pittsburg, PA) – March 2015 to September 2015
  • Ethicon, Contract Senior Program Manager (Somerville, NJ) – December 2014 to March 2015
  • Solution Systems Inc., Contract Senior Project Mgr. Consultant (Narberth, PA) – November 2011 to December 2014
  • Valsource, Contract Program Manager (Downingtown, PA) – October 2009 to October 2011
  • Schering-Plough, Contract Global Supplies Project Mgr. (Summit, NJ) – August 2009 to October 2011
  • Isogen, LLC, Contract Program Mgr., Tech Transfer (Newark, NJ) – January 2009 to July 2009
  • Schering Plough, Consent Decree Program Mgr. (Kenilworth, NJ) – 2001 to 2008
  • Ben Venue Labs, Dept. Mgr. ILP (Bedford, Ohio) – 1999 to 2001
  • Mikart Inc., Mgr. Packaging/Director Corporate Training (Atlanta, GA) – 1995 to 1999
  • Inwood Labs, Assistant Director Packaging (New York, NY) – 1995

EDUCATION

  • B.S. International Business/Marketing, Quinnipiac College, Hamden, CT – 1994

AFFILIATIONS

  • Member IOPP, PDA, ISPE

Arthur Madenjian


Consultant


Professional with solid technical and compliance knowledge, skilled in product development, plastics and mechanical engineering, R&D, and program management. Highly credentialed with years of experience in top global medical device manufacturers. Background in combination products, cardiology, balloon catheter development, peripheral vascular, neurology, urology, resection loops, orthopedic and spinal implants, oncology, drug delivery, customized coatings for medical devices.

CORE COMPETENCIES

  • Design History Files
  • Plastics Engineering
  • Current FDA Requirements
  • ISO 13485
  • Legacy Products
  • Standard Operating Procedures
  • Complaint Management Systems
  • IQ/OQ/PQ
  • Medical Devices
  • Urethral Slings
  • Prostatic Stents/Coronary Stents/Urethral Stents
  • Antimicrobial Catheters
  • Pelvic Repair Mesh Materials
  • Plastics/Polymers/Animal Based Materials
  • Shape Memory Polymers
  • Hydrophilic Coatings
  • Therapy Evaluations
  • Program Management

SELECTED ACCOMPLISHMENTS

  • Managed various project activities for medical device manufacturer of products in gastroenterology, urology, surgery, pulmonology, gynecology, and otolaryngology, including:
    • Provided regulatory compliance support to R&D, Project Management, QA, and Technical.
  • Co-Founded a company that developed and manufactured customized coatings for medical devices.
    • Created and implemented the company’s Quality Plan. Generated Corporate, Manufacturing and Quality SOP’s. Developed tests to meet performance requirements.
    • Trained personnel on work instructions. Maintained BOM’s and routers.
    • Created new chemistries & formulations to customer requirements. Utilized designed experiments to optimize formulations.
    • Developed and implemented new coating methods & techniques. Performed process validations to meet end user requirements.
    • Designed and built required equipment & tooling. Performed IQ/OQ/PQ.
    • Arranged workloads, scheduled samples and maintained equipment.
    • Developed business plan and proforma budget.
  • Consulted for an early stage developer of a new orthopedic device used to inject bone cement into fractured vertebra, and developed a manufacturing process to make this new spinal implant device including:
    • Identified key process variables and conducted designed experiments (DOE).
    • Optimized the process to improve yields from 20% to 90%.
    • Implemented the new process into manufacturing.
    • Generated procedures and trained personnel. Assured compliance to Quality Policy.
  • Reviewed Design History Files on various legacy products for completeness. Identified and rectified gaps to meet current FDA standards.
  • Re-designed existing RF resection loop to meet an unmet need. Managed all core team activities, project schedule and budget. Presented updates to Re management. Led team to successful product launch.
  • Reviewed and analyzed unresolved complaints. Rectified issues or recommended a course of action. Closed complaints out in Complaint Management System.
  • Planned the development of an office-based treatment for BPH. Solicited physician input to identify performance requirements. Planned and managed pre-clinical animal studies.
  • Initiated a program for a drug eluting ureteral stent designed for pain management. Directed a technical team toward demonstrating safety and efficacy. Planned appropriate clinical trials.
  • Evaluated urethral sling and pelvic floor repair mesh materials, including polymer and animal based materials. Identified, evaluated and selected an external supplier. Successfully worked through contract negotiations with supplier and supported distribution of the product.
  • Worked with a university partner to develop a shape memory polymer for a prostatic stent application. Defined performance specifications and testing requirements.
  • Worked with a university partner to develop a shape memory polymer for a prostatic stent application. Defined performance specifications and testing requirements.
  • Developed a business plan for the treatment of prostate cancer. Evaluated various therapies.
  • Developed and grew the hydrophilic coatings program across all of BSC’s divisions. This program grew to a multi-million dollar level. Responsible for launch of PMA approved products.
  • Integrated other coating related technologies obtained through business alliances.
  • Lead a team leader to develop a biodegradable ureteral stent. Worked with leading physicians to determine product requirements and directed the pre-clinical testing.
  • Lead a project to develop an antimicrobial catheter for the endoscopy and urology markets. Evaluated active agents & processing techniques to meet product performance specifications.
  • Developed companies first, 5Fr polyester balloon dilatation catheter, from concept to pilot production phases. This became a platform technology for the corporation.
  • Provided guidance for polymeric material selection, product design and process development.
  • Created project plans, identified scale-up requirements and provided support to manufacturing.
  • Developed various composite materials for military.

PROFESSIONAL EXPERIENCE

  • Medi-Solve Coatings, LLC, Director of Engineering (Boston, MA) – 2008 to Present
  • Independent Consultant, Principal (Winchester, MA) – 2007 to 2008
  • Boston Scientific Corporation (Natick, MA) – 1986 to 2007
  • Principle Engineer/Sustaining Engineering – 2005 to 2007
  • R&D Manager, Research and Development – 2001 to 2005
  • Program Manager, Molecular Interventions Division – 1999 to 2001
  • Senior Manager, Advanced Technology Division – 1989 to 1998
  • Senior Engineer, Balloon Catheter Development – 1986 to 1988
  • Army Materials Technology Laboratory, Materials Engineer (Watertown, MA) – 1982 to 1986

EDUCATION

  • Master of Business Administration, Northeastern University – 1993
  • Master of Science, Plastics Engineering, University of Lowell – 1985
  • Bachelor of Science, Mechanical Engineering, University of Lowell – 1982

CERTIFICATION

  • Certified Level I Thermographer, FLIR, 2007

AFFILIATIONS

  • Society of Plastics Engineers (former President of Eastern New England Section)
  • MIT Enterprise Forum
  • Medical Device Group

PUBLICATIONS, PRESENTATIONS, and PATENTS

  • Effects of Resectoscope Loop Manipulation – Journal of Endourology – 2007
  • Evaluation of a Dissolvable Ureteral Drainage Stent in a Swine Model – The Journal of Urology – 2002
  • Inventor of 12 US Patents:
    • 2006,251,581 Method of Treatment of Uterine Fibroid Tumors
    • 7,906,125 Solid or Semi-solid Therapeutic Formulations
    • 20050064045 Injectable Therapeutic Formulations
    • 7,699,769 Adjustable Surgical Sling
    • 7,476,214 Selective Coating of a Balloon Catheter for Stent Deployment
    • 7,137,966 Immobilizing Objects in the Body
    • 7,070,558 Medical Slings
    • 6,368,356 Medical Device Comprising of Hydrogel Polymers for Improved Properties
    • 6,129,737 Asymmetric Dilatation Balloon
    • 5,306,246 Balloon for Medical Catheter
    • 4,963,313 Balloon Catheter
    • 4,129,241 Dilatation Balloon

James Madenjian


Consultant


Professional with over 20 years of experience in design engineering, project management, tooling engineering, plastics and polymer engineering, and manufacturing engineering. Highly credentialed with expertise in medical device and drug manufacturing industries. Background in drug delivery balloon catheter, disposable catheter, endoscopic sheath, laparoscopic, shunt, embolic, cardiac probe, RF ablation, dissection, bioabsorbable polymer, and endosurgical devices, custom injection molded device components, and elastomeric, composite, and rubber materials.

 

CORE COMPETENCIES

  • Product Development/Design Controls Project Management
  • Specifications/Test Methods Process Validations (IQ/OQ/PQ)
  • Tool Design and Validation Statistical Process Control (SPC)
  • Failure Mode Effects Analysis (FMEA) Kaizen Techniques
  • Design for Manufacture and Assembly (DFMA) 510K Submittals
  • Design History Files (DHFs) 21 CFR Part 820/Good Manufacturing Practices
  • Design Reviews ISO 9001/ISO 13485/ISO14971

SELECTED ACCOMPLISHMENTS

  • Led technical activities for manufacturer of balloon catheters, including:
    • Conducted research and development for high pressure controlled drug delivery catheter
    • Submitted proposal for Small Business Innovation Research (SBIR) program for funding
  • Facilitated tooling activities for contract manufacturer of finished assemblies, subassemblies, and precision components for medical device manufacturers, including:
    • Designed and built tooling for plastic medical device components
    • Managed validations of 40 medical device components for customers, such as Datascope, Mini-Lab, Covidien, Suri-Quest, Chrysalis Labs, and Discovery Labs
  • Managed projects for leading medical device manufacturer specializing in efficiency and infection control solutions for flexible endoscopy, including:
    • Prepared proposal to develop low cost disposable endoscopic sheath
    • Identified materials, completed design, and developed process for fully automated manufacturer of disposable parts
  • Managed project activities for biopharmaceutical manufacturer of innovative, targeted therapies in oncology, including:
    • Coordinated Phase II and Phase III development of BPH disposable catheter system
    • Implemented process controls and training for all manufacturing processes
    • Completed 510K submission resulting in FDA approval
  • Managed design and development tasks for contract manufacturer, including:
    • Designed and built tooling for plastic medical device components
    • Validated all tooling for St. Jude Medical, Vascular Architects, United States Surgical Corp., BSC, and Neothermia Medical
  • Led medical device development and OEM group for manufacturer, including:
    • Completed Design History Files (DHFs) for laparoscopic devices, shunts, embolic devices, cardiac probes, RF ablation, and dissection devices
    • Conducted Failure Mode Effect Analysis (FMEA) with cross-functional teams
    • Led design reviews and associated meetings tasks
    • Developed production processes and conducted process capability studies to support IQ, OQ, and PQ validation work
    • Coordinated design and development efforts with medical device manufacturers, such as Boston Scientific Corp., Scion Medical, GMP, Seedling Enterprises, and TissueLink
  • Facilitated design activities for custom injection molding manufacturer of plastic components for healthcare industry, including:
    • Managed15 external customers, including tasks related to design, tooling, assembly, and transfer to manufacturing
    • Coordinated design, build, and transfer of more than $2 MM in tooling to manufacturing
    • Developed all molding processes and trained staff accordingly
    • Managed tool room, pad printing, and all secondary operations, as required
    • Implemented Kaizen process for molding operations
    • Established SPC for all new tools being transferred to production
  • Supported engineering activities for medical device manufacturer of surgical sutures and other wound closure products, including:
    • Developed tooling and injection molding technology for proprietary bioabsorbable polymers and liquid crystal polymers (LCPs) for laparoscopic devices
    • Implemented procedures and work instructions for compliance with ISO 9000
  • Completed project tasks for manufacturer of polymer materials, including:
    • Developed specifications for all plastic, elastomeric, composite, and rubber materials
    • Supported new product designs, tooling, and testing
    • Expanded polymer materials support group from one person to four people
    • Started in-house molding at three facilities, as well as implementation of prototype capabilities for sampling, with capital expenditures over $1MM
    • Developed and started-up new disposable surgical stapler
    • Developed composite “U-joints” and steering assemblies

PROFESSIONAL EXPERIENCE

  • J.M. Engineering Associates, Engineering Consultant (Marshfield, MA) – 1997 to Present
  • Clients and assignments include:
  • Medi-Solve/Medi-Balloon, Principal Investigator
  • Lacey Manufacturing, Tooling Engineer
  • Vision Sciences, Project Manager
  • Celsion Corp., Project Manager
  • Medsource, Tenax Division, Project Manager
  • Medsource, ACT Division, Project Manager
  • ACT Medical, Project Manager
  • ACT Medical, Project Manager
  • Boston Scientific Corp., Plastics Engineer
  • Tenax Corp, Project Manager, Advance Service Team (Danbury, CT) – 1995 to 1997
  • Davis & Geck, Sr. Mfg. Engineer, Advanced Engineering Endosurgery (Danbury, CT) – 1992 to 1995
  • The Torrington Co., Sr. Polymer Eng., Adv. Tech. Ctr., Materials Group (Torrington, CT) – 1985 to 1992
  • Texas Instruments, Inc., Mfg. Engineer, Molding (Attleboro, MA) – 1979 to 1985
  • Davol, Manufacturing Engineer (Cranston, RI) – 1978 to 1979
  • Smith-Corona, Materials Engineer, Technical Resource Laboratory (Cortland, NY) – 1976 to 1978
  • General Electric, Adv. Mfg. Engineer/Plastics Specialist/Sr. Project Eng. (Providence, RI) – 1972 to1976

EDUCATION

  • Master of Science, Plastics Engineering, Lowell Technological Institute
  • Bachelor of Science, Plastics Engineering, Lowell Technological Institute

CERTIFICATION

  • ISO 13485 Internal Auditor Certification, Central Connecticut State University (CCSU)
  • Project Management, Central Connecticut State University (CCSU)

TRAINING

  • Six Sigma Black Belt
  • General Electric Manufacturing Management Program
  • The Torrington Co., Total Quality Management Program
  • Davis & Geck Quality Education System
  • Tenax Quality Education System