Cell Culture and Sterile Drug Product Development Expert specializing in, Technology Transfer, Scale-up, and Manufacture
Technical Consultant #1892
- 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.
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.
- Ph.D. Chemical and Biochemical Engineering, Rutgers University, New Brunswick, NJ
- B.S. Chemical Engineering, Cornell University, Ithaca, NY