Pharmaceutical and Biotechnology Product Development, Compliance and Quality Expert

Technical Consultant #2344


Expertise

  • Pharmaceutical and biotechnology product development, management of cGMP compliance quality systems, quality control, quality assurance, (in unique dosage forms, and sterile-nonsterile processing methods).
  • Laboratory quality systems for both pharmaceutical development and quality control testing.
  • Complete laboratory outfitting including qualification and method implementation.
  • Test method development, transfer and validation.
  • Analytical measurement and techniques.
  • Auditing systems and processes.
  • Analysis of APIs, raw materials, controlled release formulations and biodegradable polymers.
  • cGMP compliance with current industry standards and regulatory expectations (FDA/ICH/EMA/ISO).
  • System of standard operating procedures, test methods, specifications, validation protocols and reports.
  • Development and establishment of stability testing programs.
  • Standard operating procedures, test methods, specifications, validation protocols and reports.
  • Development of training curricula and conducting personnel training.

Experience

Undisclosed Company, Director-Scientific Affairs, 2013 - Present

  • Authored and established quality agreements with customers and contract testing laboratories.
  • Coordinated efforts between company's sites in harmonizing quality control procedures for testing polymers.
  • Identified and harmonized best practices among their quality control laboratories.
  • Authored multiple business line standard operating procedures providing frame work for various sites to develop comparable local procedures.
  • Developed and executed validation testing requirements during site implementation of the electronic quality management system TrackWise.
  • Authored associated standard operating procedures, developed training curricula and trained site personnel on TrackWise modules.
  • Provided audit support during customer and agency audits.
  • Contributed to reducing the site quality backlog by driving completion and closure of outstanding CAPAs and Deviations.
  • Developed costing model for laboratory test pricing and stability study pricing for new project proposals.
  • Ensured ICH Q3D compliance for the polymer excipients at the site by leading a team in conducting the necessary risk assessment and confirmatory testing.
  • Project lead for overhauling site processes for materials.

Head of Quality Control. 2014

  • Successfully hosted an ISO13485 audit resulting in site re-certification.
  • Hosted multiple customer audits.

Director, Quality Control and Analytical Laboratory, 2005 - 2013

  • Developed laboratory systems from scratch to service both development of controlled release formulations and quality control testing for manufacturing activities upon inception of Brookwood Pharmaceuticals.
  • Successfully completed the transfer of all test methods associated with the manufacture of biodegradable polymers as part of technology transfer activities from previous manufacturer.
  • Established the method transfer program for transferring client methods to support formulation development activities.
  • Established the program for compendial method qualification to support raw materials testing.
  • Established the program for developing and validating test methods in compliance with ICH and USP/EP requirements for polymers and unique sterile formulations including liposomes, encapsulated protein microparticles, peptide-containing implants, injection vehicles and novel API controlled release formulations.
  • Designed and deployed the company stability program to ensure compliance with ICH requirements.
  • Designed stability studies of polymer excipients and controlled release formulations to support establishment of product shelf life.
  • Successfully completed the transfer of all test methods associated with the manufacture of a sterile liposome formulation.
  • Established the quality procedures within the QC laboratories to ensure compliance with regulatory (FDA, EMEA and ISO) requirements and customer expectations as demonstrated by successful customer audits, QP audits and audits by ISO certification bodies and the regulatory agency MHRA.
  • Successfully prepared and presented the Quality Control laboratories for regulatory inspection by the MHRA, resulting in approval to conduct testing in support of sterile product release for the European market.
  • Developed training plans and curricula for QC analysts to ensure consistent training requirements for laboratory activities. These were eventually incorporated into the company's training program Successfactors.
  • Identified and monitored KPIs for laboratory metrics.
  • Member on client project teams providing technical support and oversight in the development of test methods for controlled release formulations, raw materials and biodegradable polymers.
  • Authored CMC documentation for client regulatory filings to support the approval of a new injectable product for the European market.
  • Designed the QC the laboratory layouts for the new facility commissioned by SurModics. Coordinated and oversaw the successful transfer of activities to the new laboratory and re-qualification of equipment with minimal disruption to lab services and testing.

University of Alabama, Birmingham, AL, Chemistry Instructor, 2004 - 2005

  • Instructor: General and Organic Chemistry.

Durect Corporation, Birmingham, AL, Director Analytical Chemistry, 2002 - 2003

  • Department representative on company project teams and interacted with clients on project-related analytical issues.
  • Responsible for establishing and maintaining departmental budget.
  • Oversaw the design and renovation of the analytical laboratory to increase laboratory bench space and provide much needed additional space for laboratory equipment.

BioCryst Pharmaceuticals, Inc., Birmingham, AL, Director, Analytical Development, 1992 - 2002

  • Managed routine quality control testing of raw materials, finished product and stability samples in support of pharmaceutical development activities.
  • Standardized training procedures for personnel in the QC laboratory. Department representative on company project teams. Responsible for establishing and maintaining departmental budget.

Section Head, Analytical Chemistry

  • Increased supervisory responsibilities.
  • Continued method development and validation for new potential drug candidates, measuring their content in different types of pharmaceutical products in development such as creams, capsules and IV injections for use in clinical studies.
  • Introduced USP Type I and II dissolution testing to the site. Developed and validated dissolution methods.

Group Leader, Analytical Chemistry

  • Increased supervisory responsibilities.
  • Conducted personnel training. Conducted training on various cGMP activities and writing of SOPs.
  • Developed and validated new test methods for new chemical entities and drug products.
  • Established laboratory procedures for conducting stability studies of active pharmaceutical ingredients and clinical trial materials according to regulatory requirements.

Research Scientist

  • Established new analytical laboratory after the company moved to a larger facility.
  • Created procedures for sample receipt, tracking and testing in new facility to comply with GMP requirements.

Laboratory Supervisor

  • Developed methods for testing raw materials and new chemical entities being synthesized by company chemists.
  • Identified and purchased the necessary equipment to conduct MS, FTIR, UV-Vis and HPLC testing of materials.
  • Set up stability studies of active pharmaceutical ingredients and clinical trial materials according to regulatory requirements.

Jefferson State Community College, Birmingham, AL, Chemistry Instructor, 1991 - 1992

  • Instructor of introductory level chemistry.

Alabama Department of Forensic Sciences, Birmingham, AL, Forensic Scientist, 1990 - 1992

  • Toxicology Analyst: Extracted biological fluids to determine the presence, identity and quantity of various illicit and prescription drugs. Documented results in reports for use in criminal investigations.

Honors & Publications

Languages

  • Polish

Academic and Professional Affiliations

  • American Association of Pharmaceutical Scientists
  • Parenteral Drug Association

Publications

  • Author and Co-Author of numerous publications in peer reviewed journals and educational text.

Education

  • Ph.D. Physical Organic Chemistry, Auburn University, Auburn, AL
  • B.Sc. Chemistry, University of Manchester-Institute of Science &Technology Manchester, England
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