Steven Zilli, Ph.D.

Consultant

• (610) 462-4090
• info@qualitysolutionsnow.com

Senior Pharmaceutical Professional with over 35 years of diverse and progressive technical and compliance knowledge in R&D quality assurance, regulatory compliance, manufacturing, quality control, and packaging Experience working in start-up and leading global pharmaceutical companies. Background in tablets, extended release tablets, tamper resistant tablets, capsules, oral liquids, parenterals, soft gelatin capsules, transdermal patches, and buccal films.

CORE COMPETENCIES

• FDA/DEA/International Agency Inspections/Remediation
• External audits/Supplier Audits
• PAI Readiness/ Mock PAI
• Pharmaceutical QA/ Regulatory Compliance in commercial manufacturing and R&D
• Validation (Process, Cleaning, Analytical Method, Computer, Equipment)
• Failure Investigations/Root Cause Analysis
• Corrective and Preventative Actions (CAPA)
• Operations Management
• Quality system Requirements
• Technology Transfers
• Training Programs/Records
• CMC Review/Remediation

SELECTED ACCOMPLISHMENTS

• Provided complete GMP /Quality Assurance coverage to start up contract Development Company and major pharmaceutical companies, including:
  • Provided GMP guidance to development teams.
  • Performed GMP audits of API, contract manufacturers, contract packagers, analytical labs, and excipient manufacturers.
  • Reviewed all GMP documentation for API, excipients, packaging components and finished product including: specifications, methods, batch records, packaging records, process validation, investigations, change controls, labeling.
  • Reviewed CMC sections for DMF, IND and NDA approval.
  • Wrote and reviewed SOPs needed by product development organization.
• Managed multiple projects for major drug manufacturer of controlled substances, semisolids, novel dosage forms and solutions, including:
  • Acted as Interim Head Analytical technical support while retaining R&D QA responsibilities
  • Cohosted two FDA inspections with zero observations.
  • Provided manufacturing, equipment and facilities expertise as part of an audit team assembled to perform a for cause audit of the companies commercial sites.
  • Provided GMP and technical support to a variety of dosage forms from IND through NDA approval, including: tamper resistant extended release tablet containing a controlled substance, transdermal patches, a soluble buccal film, topical gels, and sterile products (IV and intramuscular).
  • Performed Mock Preapproval inspections.
  • Coordinated PAI readiness.
• Directed multiple activities for a contract development/research and clinical/commercial manufacturing company providing services to pharmaceutical and biopharmaceutical companies, including:
  • Established all Quality systems
  • Hosted a FDA PAI, two other FDA inspections and multiple DEA inspections without observations.
  • Completed IQ, OQ and PQ of analytical equipment, manufacturing equipment, stability chambers, air handlers, computers, water systems, and clean compressed air.
  • Wrote or reviewed SOPs for cleaning, maintenance, calibration of equipment and facilities.
  • Provided GLP support to analytical testing of test articles.
  • Conducted training (this included formal GMP presentations and one on one on the job training in clinical packaging, USP concepts, inventory control, and manufacturing).
• Led multiple efforts for drug/biologics manufacturer of innovative medicines, vaccines, biologic therapies, consumer care and animal health products, including:
  • Provided GMP support to Part 11 remediation of R&D.
  • Provided GMP support to a group formed to speed nominated development projects to IND filing.
• Managed and provided GMP and technical support for high profile, no fail projects at a multinational Pharmaceutical company including:
  • Coordinated efforts between: analytical R&D, API Led GMP and technical remediation efforts at a single source API supplier (this required 6 months of onsite supervision of manufacturing, R&D, pharmaceutical R&D, commercial manufacturing, the contract site and corporate planning).
  • GMP responsibility for an AIDS drug through NDA approval.
  • Served as member of team to remediate warning letter deficiencies at Puerto Rican company site
  • Responsible for GMP aspects of the renovation of a commercial manufacturing and packaging site
  • Represented manufacturing on a team to reformulate a soft gelatin capsule.
  • Led technical transfer and launch efforts at a commercial manufacturing site to launch a new product
  • Hosted 5 FDA inspections, a MHRA inspection and multiple DEA inspections with no serious observations.
  • Provided GMP support to installation and validation of purified water systems.

PROFESSIONAL EXPERIENCE

• Zilli Consulting, LLC, President (Chaddsford, PA) – 2013 to Present
• Endo Pharmaceutical, Manager R&D QA (Chaddsford, PA) – 2007 to 2013
• QS Pharms, Director Quality Assurance, (Boothwyn, PA) – 2002 to 2007
• Merck, Senior GMP Compliance Administrator, (West Point, PA) – 2002 to 2002
• DuPont Pharmaceutical, Senior Quality Assurance Scientist, R&D QA (Wilmington, DE) – 1995 to 2001
• DuPont Pharmaceutical Senior Process Pharmacist, (Garden City, NY) – 1993 to 1995
• DuPont Pharmaceutical Manager Regulatory Compliance, (Garden City, NY) – 1991 to 1993
• DuPont Pharmaceutical Senior Scientist, Central Manufacturing Technology, (Garden City, NY) – 1990 to 1991
• DuPont Pharmaceutical Section Supervisor Bulk Manufacturing, Chemical Processing, and Contract Manufacturing, (Garden City, NY) – 1986 to 1990
• DuPont Pharmaceutical Supervisor Packaging, (Garden City NY) – 1984 to 1986
• DuPont Pharmaceutical Supervisor Bulk Manufacturing, (Garden City NY) – 1981 to 1984
• DuPont Pharmaceutical Chemist, Quality Control, (Garden City, NY) – 1979 to 1981

EDUCATION

• Ph.D., Industrial Pharmacy, St. John’s University, New York, NY – 1989
• MS, Industrial Pharmacy, St. John’s University, New York, NY – 1983
• BS, Chemistry, Hofstra University, Hempstead, NY – 1978

AFFILIATIONS

• American Chemical Society, 1974 – Present

PUBLICATIONS AND PRESENTATIONS

• Zilli and Nash, “Mixing of Acetaminophen and Lactose in a V-Shaped Blender, An Example of a Total Mixture”, Pharmaceutical Engineering, vol. 12, pp 54 (1992)