Injectables, Solid and Liquid Dosage Microbiology, Quality, and Regulatory Affairs Expert

Expertise

• Over 33 years' experience in quality, microbiology and regulatory affairs.
• Pharmaceutical assessments, prioritization, establishment of realistic timelines for the implementation of consent decree commitments and 3rd party certifier of deviations-investigations.
• Ensure the robustness of quality systems - change control, product complaint handling, revision of SOPs, and control of 3rd parties.
• Quality assessment of sterile injectable, small molecules and biological as well as other dosage forms.
• Solid and liquid oral dosage forms, medical devices, and solid, semi-solid and liquid OTC products.
• Team Lead Inspector: FDA, EMA, MHRA and Health Canada inspections.
• SME in the establishment and review of Environmental Monitoring programs for all controlled areas.

Experience

Undisclosed Company, Principal, 2009 - Present

Quality Systems, Quality Assurance and Microbiology Consultant

• Provide small molecule, biologics companies having dosage forms that include sterile drugs (terminally sterilized and aseptic fills), solid oral dosage forms, liquid oral dosage forms and topical products.
• Executing both auditing and gap analyses and remediation.
• Subject Matter Expert in pharmaceutical microbiology: Plant and water system controls and sanitization, deployment and analysis of appropriate and compliant Environmental Monitoring programs.
• Lead audits of quality systems perform gap analysis, recommend and help implement remediation programs.
• Experienced in the remediation of validation plans for sterilization, cleaning, and plant sanitization.
• Consent decree commitments and 3rd party responsibilities, including the certification of deviations and remediation.
• Successfully mentored investigations for deviations originating in QA, QC and the manufacturing environment, to ensure that investigators develop a clear understanding of the elements of a successful investigation - candor, brevity and focus on true root cause. Imbue investigators with a sense of the 'inspect ability' of their investigations, e.g. prompt closure, interim corrective actions, when appropriate, and proper root cause analysis /effective CAPA.

Savient Pharmaceuticals, East Brunswick, 2002 - 2009

Senior Vice-President, Worldwide Quality and Regulatory Affairs, 2006 - 2009

• Reported to the President and CEO, crafted and implemented compliant Quality Systems and established a consistent Regulatory philosophy Corporate-wide - involving all domestic and offshore contract manufacturing and testing facilities.
• Developed strategies for interactions with FDA on Pre-IND, Post Phase 2, Pre-BLA and other strategic meetings with the Agency. Other responsibilities retained as outlined below as Vice-President, corporate QA.
• Successfully drove the on-time filing of the company's first Biologics License Application (BLA) in eCTD format for the anti-gout drug Krystexxa®. The filing was accepted, granted Priority Review status by the Agency and has been approved by FDA.
• Crafted QA compliance auditing program and expanded it to a multi-disciplinary pre-emptive team to ensure the successful Pre-approval Inspection (PAI) preparation of manufacturing, testing and clinical monitoring sites. PAI outcomes were positive, with most sites receiving no FDA 483 observations, leading to the approval of Soltamox® and Krystexxa.
• Replaced a cumbersome manual document and SOP management system with a GMP compliant, fully validated system, working in close cooperation with client departments (Clinical, Medical Affairs, Human Resources) in a successful collaboration with the Corporate IT department.
• Managed field alerts on a solid oral dosage form (DEA Schedule III) in close collaboration with the agency such that each was resolved without incident or negative impact upon the involved batches or the drug supply.
• These accomplishments benefitted from a carefully crafted strategy to maintain good relationships and timely communications with the Agency.

Vice-President, Corporate Quality Assurance, 2002 - 2006

• Reported to the Senior Vice-President, Worldwide Quality and Regulatory Affairs.
• Oversaw and developed quality initiatives for new market introductions, existing drugs, new product acquisitions and drugs in clinical development.
• Ensured compliance with cGMPs, cGLPs and cGCPs at both domestic and offshore sites.
• Formulated CMC sections of submissions, collaborated with Regulatory Affairs and interacted with FDA on prior approval and Changes Being Effected (CBE) filings.
• Devised and directed auditing programs for contract manufacturers, contract packagers (clinical trial material and marketed product), and clinical study sites.
• Enhanced and assured the compliance of Corporate Quality Systems, internal audits and training programs.
• Managed the NDA submission for Soltamox liquid (solublized tamoxifen) and the required offshore manufacturing facility modifications to achieve a successful PAI, and an on-time approval for the drug, with no post-approval commitments.
• Received a commemorative award from the CEO for successfully negotiating an expedited review with FDA for a prior-approval supplement for Delatestry®, following the unexpected shutdown of a contract manufacturing and testing facility.
• Review and approval of the new manufacturing facility and a separate testing facility occurred in less than 60 days, with no follow-up inquiries by the Agency prior to approval.
• Headed an interdisciplinary team charged with the responsibility for moving specialized pharmaceuticals marketed by a European subsidiary into the U.S. market.
• Oversaw the FDA-readiness initiative for overseas facilities in Israel and the U.K.
• Submitted two additional supplements to the Agency that were approved without a request for additional information.

The Quantic Group Ltd., Livingston, NJ, Quality Assurance Consultant, 2001 - 2002

• Developed and instituted quality solutions within client companies at domestic and offshore sites. Specific responsibilities included a gap analysis of the quality processes, validation, benchmarking, establishment and implementation of best practices for analytical and microbiological analyses (CMC).
• Established and oversaw training programs for microbiological laboratory personnel.

Carter-Wallace, Cranbury, NJ, Vice President, Quality Standards, 1987 - 2001

• Reported to the Senior Vice President of Corporate Quality, responsible for corporate SOPs, quality and regulatory status of QA/QC procedures, programs, and specifications throughout the company's five operating divisions, including Quality Assurance operations at two domestic sites and four international subsidiaries.
• Acted as primary company interface with FDA on documentation systems, validation, and QA and QC issues.
• Designed and implemented a document management system (CFR Part 11 compliant) for the circulation, review and approval (electronic signature) of all Corporate SOPs that shortened turn-around time by 80%, provided a three-year ROI, and a cost savings thereafter of $300 thousand annum.
• Launched and oversaw the completion of a program for the company-wide conversion of all ethylene oxide component sterilization to gamma irradiation sterilization processes validated for parametric release in accordance with AAMI standards. Annual savings of $450 thousand, with a 55% reduction in average component lead times, from 18 to 8 days.
• Identified the causes of a finished, packaged medical device stability problem, averting a recall with a direct cost of $400 thousand and estimated indirect costs (loss of market share) of more than $50 million.
• Led a team that solved a product stability problem with a liquid suspension product (antacid); recommended and helped implement the solution, allowing a cost avoidance of $1 million.
• Responsible for the operation of the Microbiological Services department and the oversight of microbiological laboratories and initiatives at six other plant sites, both domestic and offshore.
• Developed and implemented a naturally derived preservative system in an "all natural" product, resulting in the elimination of parabens.

Bristol-Myers Squibb, New Brunswick, NJ, 1984 - 1987

Senior Section Head - Laboratory Operations

• Developed new methods for the analysis of antibiotic and vitamin potency.
• Ensured that the methodology used in the laboratories was state of the art.
• Managed a group of 5 professional research scientists, as well as 3 Supervisors and 20 bench operators.

Honors & Publications

Academic and Professional Affiliations

• Served on a Panel of Experts for USP Microbiological Expert Committee
• Session speaker at the Annual USP Conference
• Attended a meeting between FDA and PhRMA representatives on the PAT initiative
• Acted as a Moderator for the Joint USP-PDA Joint Conference on Sterile Product Manufacturing
• Chairman, New Jersey Pharmaceutical Quality Control Association). Honored for continued contributions to the Organization and its initiatives.
• Member, Parenteral Drug Association; American Society for Microbiology
• Corporate Member, PhRMA
• PDA Beta-Lactam Products Sub-Committee
• Selected by PhRMA as its representative to the US Technical Advisory Group (TAG) for ISO/TC 209 - Sterility Testing and Cleanroom Technology
• PhRMA Aerosol Dosage Forms Committee
• PhRMA Pharmaceutical Water Quality; Microbial Limits Committees

Education

• Ph.D. Microbiology and Biochemistry Rutgers, The State University, New Brunswick, NJ
• M.S. Microbiology and Biochemistry Rutgers, The State University, New Brunswick, NJ
• B.S. Biology, Adelphi University, Garden City, NY