Cell Culture and Sterile Drug Product Development Expert specializing in, Technology Transfer, Scale-up, and Manufacture

Technical Consultant #1892


Expertise

  • Fermentation and cell culture development, scale-up, and manufacture.
  • Sterile drug product development, technology transfer, and manufacture.
  • Current good manufacturing practices (cGMP).
  • Metabolic modeling.
  • Educator for undergraduate Bioengineering program and workshop facilitation.

Experience

Undisclosed Company, Owner, 2011 - Present

  • Provide technical expertise in pharmaceutical processing and manufacture to clients.

Undisclosed University, Professor of Practice, 2008 - Present

  • Teach courses in Chemical Engineering and Bioengineering.
  • Current courses: Metabolic Engineering, Integrated Biotechnology Laboratory, Sophomore Research Seminar.
  • Past courses: Engineering Physiology Laboratory, Bioengineering Design.
  • Advise inter-disciplinary student teams working on their capstone design projects.
  • Lead operations for the undergraduate Bioengineering Program, including management of accreditation activities, curriculum changes, and course scheduling.
  • Advise undergraduate students.

Bristol-Myers Squibb, 2000 - 2008

Manager and Group Leader, Protein Therapeutics Development, Process Operations, 2006 - 2008

  • Managed cell culture operations and materials management for process scale-up activities and early phase clinical manufacture in the biologics development laboratory. Direct reports included a team of engineers, scientists, and materials administrators, including BMS employees and contractors.
  • Designed scale-up studies, evaluated process and analytical data, wrote and reviewed technical reports and presentations, and performed process troubleshooting.
  • Led activities in cGMP operations, including batch record review, completion of quality events and investigations, identification and implementation of corrective and preventive actions, and training plan development.
  • Developed procedures for sampling, testing, and management of raw materials and consumables to be used for clinical manufacture.
  • Wrote and reviewed departmental standard operating procedures.
  • Collaborated with BMS colleagues within the department and on cross-functional development and technology transfer teams, including quality, global engineering, facilities, drug product development, analytical development, and commercial manufacturing.
  • Responsibilities expanded at end of tenure to include purification operations and reagents production for pipeline and commercialized products.

Senior Research Investigator, Research and Development, Drug Product Process Development, 2005 - 2006

  • Supported technology transfer of intravenous and subcutaneous biologics products from research and development to the commercial manufacturing sites.
  • Co-developed pilot-scale ultrafiltration and diafiltration process.
  • Performed laboratory studies to support a biologics drug product stability investigation.
  • Authored and reviewed drug product manufacturing sections for health agency submissions.

Technical and Senior Technical Investigator, Global Pharmaceutical Technologies, 2000 - 2005

  • Facilitated technology transfer for sterile liquid and lyophilized products, including biologics and small molecules, from research and development to the commercial manufacturing sites. Co-led technology transfer teams. Supported the manufacture of clinical, stability, and validation batches.
  • Authored drug product manufacturing sections for health agency submissions.
  • Wrote and reviewed protocols and reports for process justification, container closure, and stopper coring and extractables studies.
  • Provided frequent on-site technical support for commercial products.
  • Managed transfer of intravenous bag product manufactured at third party contractor.
  • Mentored undergraduate and graduate interns.

International Specialty Products, Wayne, NJ, Research Engineer, 1993 - 1995

  • Improved and developed pilot-scale processes for synthetic polymers.
  • Wrote process instructions for pilot plant technicians.
  • Oversaw start-up operations of new processes at ISP plants and contract manufacturers.

Honors & Publications

Academic and Professional Affiliations

  • International Society for Pharmaceutical Engineering (faculty adviser for Lehigh chapter), American Institute of Chemical Engineers, Society for Biological Engineering
  • American Chemical Society, Biomedical Engineering Society

Publications and Patents

  • Co-Author of collegiate text books and courses.
  • Co-Author - abstract for Journal of pharmaceutical and biomedical analysis.

Education

  • Ph.D. Chemical and Biochemical Engineering, Rutgers University, New Brunswick, NJ
  • B.S. Chemical Engineering, Cornell University, Ithaca, NY
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