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

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