Elyse has been involved during various project phases in the design of retrofitted, brownfield, and greenfield sites. Her experience includes cell and gene therapies, vaccines, monoclonal antibodies (mABs), creams and ointments, final formulations, and Active Pharmaceutical Ingredients (API), with a primary focus in biotech projects.
Regulatory requirements change slowly, but industry practice is increasingly affected by two key factors: technological advances and quality requirements. The intersection between long-standing regulations and new technology is often found in best practice guides published by accrediting bodies or professional associations like the International Society of Pharmaceutical Engineers (ISPE).
Jeff’s 25+ years of experience in the biopharmaceutical industry has included the development and delivery of many of the industry’s major manufacturing projects, consulting roles in compliance and strategic planning, and development of many of the industry’s key reference and guidance documents. These projects represent a global capital investment of more than $3B and the production of many of the key biopharmaceutical therapeutics and vaccines licensed today.