The VP/SVP will report into the COO and will have a high degree of visibility, influence and executive decisions within the company. The ideal applicant would have a strong strategic approach and a track record of experience leading technical operations, such as process and analytical development, Clinical and Commercial Manufacturing from end to end. This position will also be in charge of the supply chain for clinical and commercial biopharmaceutical assets.
- Responsible for the long-term strategic planning and implementation of the company's clinical and commercial manufacturing and supply strategy, as well as the management of process, manufacturing, and supply teams to drive product-specific technology and capability investment, including the acquisition of a pilot plant and/or commercial plant if necessary.
- Recruit and develop talent across process and analytical development, as well as manufacturing, to create a high-performing team.
- Establish a fit-for-purpose and phase-appropriate manufacturing and supply strategic plan based on the product value inflection point, CMO footprint, buy-to-own possibility, and other factors.
- Promote a quality-oriented culture and guarantee that all actions and paperwork meet regulatory criteria. Understand and implement systems, controls, and methodologies that are compliant with global health authority regulations.
- Advanced degree in Medical or Life Science (Ph.D. in Biological Sciences, Chemical Engineering, Chemistry, or related discipline).
- 10+ years progressive experience in a key leadership/management role in pharmaceutical development especially for late stage and commercial manufacturing.
- Experience managing fc-fusion proteins and antibody based products through the clinic to commercialization.
- Demonstrated track record of success in preparing and defending CMC submissions in clinical and market applications for FDA and foreign regulatory authorities.