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Quality Control

San Francisco, CA
August 21, 2012

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Paul H. Friedman, Ph.D.

510-***-**** / 415-***-****

Dr. Paul Friedman; Quality professional with over 15 years of experience in the technical, operational, and compliance management of QC organizations. As a bench chemist, manager/director, and consultant, he has consistently and successfully led laboratory organizations for quality and efficiency while emphasizing teamwork and continuous improvement. He efficiently combines compliance with technical expertise to achieve continuously improving operating efficiency while maintaining practical and effective compliance.

Projects 2009 to Present

Lead product quality analysis for an OTC manufacturer and evaluating quality systems programs and performing risk analysis associated with compliance options.

Assist a major injectables manufacturer in quality program remediation, complaints evaluation, investigation resolution, and batch record review.

Supporting cleaning validation projects: project planning, experimental design for cleaning validation and validation of analytical methods for validation

Advising on methods development and validations for a start-up developing a polymeric gastro-intestinal drug targeting hyperkalemia.

Value stream mapping of a Pharmaceutical QC laboratory for a new build-out

Advised on 483 remediation of methods validation issues for a small generic injectables manufacturer revising SOPs and protocols; developing photostability evaluation chamber and procedures

Product Quality Analyst/Team Leadr for a major generic injectables supplier and a solid dose manufacturer performing a variety of functions

o Reviewing batch records for compliant conformance to MBR

o Review scientific validity and compliance of OOS investigations and implement corrective actions

o Reviewing analytical release data for conformance to cGMPs and in-house SOPs

o Reviewing and modifying manufacturing and laboratory SOPs for consistency and technical accuracy

o Auditing laboratory procedures, personnel, and systems for adherence to methods and for compliance

o Reviewing Validation protocols and reports for conformance to validation requirements

Acting QC Director for a nutraceutical developer/manufacturer

o Managing compliance issues

o Improved complaint management system for greater responsiveness

o Initiated Company-wide training in cGMPs

o Wrote new OOS investigation SOP

o Initiated change control procedures

2008 – 2009 Associate Director, QA – Validation, Elan Pharmaceuticals;

Validating antibody methods and assuring standards (GMP, GLP, ICH USP) are met/ Writing, reviewing & approving plans, protocols, reports, SOPs and reviewing analytical data

2008 Director, Analytical Services Leiner Health Products

Leading the Analytical Development/Validation and Method Compliance Program for a large Nutraceutical developer and manufacturer;

o Directed QC laboratory performing release and stability analyses, process troubleshooting

o Introduced 5S procedure to improve laboratory operation

o Wrote and implemented SOPs for investigations, management of laboratory quality system

Projects 2006 – 2008

East Bay, CA start-up

o Set up in-house laboratory to support formulations development and trained analyst

o Collaborate with CROs and CMOs on methods supporting registration and formulation/manufacturing of orally absorbed sleep aide

o Write and review CMC sections for NDA and SOPs

SF Bay Start-up Topical Registration

o Assure QC and stability cGMP compliance – upgrade protocols and reports

o wrote & reviewed CMC sections of NDAs/CBE-30s, SOPs;

o audited laboratories and manufacturing facilities;

o mentor QC personnel;

o develop and monitor stability programs for submissions

Director of Technical Quality Affairs – 2005 – 2006 - Sepracor – Marlborough, MA

o Partnered with CMOs for method development, validation, and transfer of analytical methods for API, formulations, and impurities

o Led extractables study for MDI product

o Work with CMOs on laboratory investigations

Project - 2004

Product Quality Analysis for an OTC-Generic-Nutraceutical Producer

o Investigate alleged fraud in laboratory operations

o Evaluate laboratory capacity

o Review laboratory OOS investigations for technical completeness

o Audit instrumental outputs and written laboratory records

Project 2003-2004

Consultant to Virtual Generic Injectables Producer

o Developed and reviewed SOPs for method validation and method transfer

o Developed stability protocols

o Wrote SOPs for quality program overview supporting partnered contractors

o Advised on method issues and investigations

2002 - 2003 Bayer Health – Berkeley CA, - Deputy Director – QA Biotech Development

Directed the QA program for Bayer’s biotech product and process development efforts

2000 – 2002 Wyeth – Marietta, PA – Associate Director, Quality Control – 2000 – 2002

Quality Control, Compliance, Analytical Development & Services

Directed the Analytical - QC/Chemistry of Wyeth's vaccine operations at Marietta, PA – 4 direct reports – 50 people. As Associate Director of QC – Chemistry

Accomplishing projects and programs by:

o Managed re-validation of all methods used on the site

o Successful negotiations with monitors/consultants leading to finalization and fulfillment of Consent Decree Inspection Observation Findings (IOF) requirements

Successful projects included:

o Developing compliant and efficient laboratory sample and information management systems

o Simplifying the discrepancy management/CAPA and OOS systems for manufacturing and laboratories.

o Co-leading the development of a new raw material management system

1993 – 2000 Block Drug Company, Jersey City, NJ – Section Chief – QC/Analytical Services 4 direct reports – 4 Lab Sections – 45 people;

1998 – 2000 Block Drug Co. Analytical Development

o Reduced investigation times and turn-around times leading to centralization of world-wide stability in our facility

o Led the group developing and validating all analytical methods

o Wrote, and/or revised methods, specifications, SOPs

o Worked with QA, Production, and Regulatory Affairs to aid in method transfers.

o Managed the analytical support to Stability, Complaint Failure, Process Development, and Product Development

o Oversaw investigations for OOS’ and led CAPAs

Ph.D./MS University of Michigan – Ann Arbor

BA New York University

Awards: Block Drug Co. Research and Technology Excellence Award


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