Gary Potter Email & Phone Number

Milpitas, CA, US

Amsterdam, 1105BP, NL

Manage Operations staff of 70 in the production of proprietary gene therapy products. This includes manufacturing, facilities/engineering/validation, manufacturing science and technology (MSAT), and supply chain, operations at the Lexington, MA site, as well as managing the GLP facility and supply chain operations at the Amsterdam, NL facility.Team.

Ames, IA, US

• Headed up Manufacturing and Supply Chain staff of 30 in the production of early and late-phase anti-cancer clinical products. This included the internal production of the company’s proprietary whole-cell products, as.
• Directed start-up and operation of new aseptic manufacturing facility.
• Led manufacturing staff of 20 in cell culture, harvest, formulation, and filling of company’s Phase I, II, and III mammalian whole-cell HyperAcute anti-cancer products.
• Restructured manufacturing organization to clarify roles and responsibilities resulting in higher employee retention and a 50% reduction in time required for new-employee training and qualification.
• Created and staffed process development team. This team successfully developed, MFG processes of new cell lines, evaluated new potential production platforms, decreased run-to-run variability, and increased the yield.
• Developed and implemented Tech Ops function to ensure effectiveness of SOPs and increase cGMP compliance in training, deviation investigations, and change-control resolution.

US

Provided manufacturing and facility start-up expertise for three projects.

Hayward, CA, US

• Led manufacturing operations staff of 35 in production of Phase III mammalian whole cell anti-cancer product. Worked cross-functionally to ensure achievement of production, regulatory compliance, quality assurance, and.
• Directed mammalian cell culture production, harvest, formulation, filling, and technical operations functional areas to ensure achievement of production and compliance goals.
• Served as manufacturing representative on cross-functional team responsible for scaling up 50L clinical process to 500L commercial launch process.
• Reorganized and developed operations staff to create high-functioning team by building reporting structure to take advantage of individual’s strengths and ensuring clarity and alignment of roles with corporate.

• Defined functional and operational upstream requirements for new 2K to 12K clinical/commercial manufacturing facility. Functional areas included inoculum scale-up, cell culture production and harvest, as well as media.
• Worked with contract engineering firm CRB to ensure the design of the upstream equipment (bioreactors, in-line centrifuges, media prep vessels, and transfer panels) met operational requirements.
• Designed robust sterilization, production, and clean in place processes to ensure product quality and sterility.
• Reviewed and approved commissioning and validation (IQ, OQ, and PQ) protocols
• Served as the lead cell culture manufacturing representative on a multifunctional teams responsible for: tech transfer, writing and approving process validation protocols and summary reports, and generation of the BLA.
• Hired and led a cell culture manufacturing team of 26 that maintained a 97% success rate from start-up through PAI. This included production of the conformance batches for commercial launch.

• Headed up a tech transfer team responsible for transferring a microbial manufacturing process from Alameda, California to a CMO in Kundl, Austria for phase I production. Worked cross-functionally to ensure all.
• Person in the plant for tech transfer into CMO pilot plant and then into clinical production facility.
• Worked cross-culturally to coordinate meetings and information flow to meet project objectives.
• Assisted in additional tech transfer of mammalian cell production process from Baxter’s Orth, Austria facility to new manufacturing facility in Neuchatel, Switzerland. Used interpersonal skills to provide process.

• Led cell culture staff of 8 in the start-up and licensure of new manufacturing suite. Trained staff in upstream operations and cGMP compliance.
• Executed validation procedure (IQ, OQ, and PQ) for the new manufacturing equipment.
• Worked with validation staff to redesign the SIP validation philosophy to align with intended operational use.
• Hired and trained additional staff to meet production goals.
• Functioned as the cell culture manufacturing representative on tech transfer team to incorporate new manufacturing process from Orth, Austria.