Vice President, CMC
AnaptysBio is seeking to attract a key member of its senior leadership team to be the Vice President, CMC with the mandate to provide the vision, leadership, strategy and management skills to oversee, lead and further expand the manufacturing of company’s proprietary programs through preclinical, clinical and commercial stages. In particular, the VP of Manufacturing will have oversight over the company’s entire out-sourced manufacturing effort, including Phase 3 and commercial manufacturing as the company’s ANB020 and ANB019 programs advance beyond Phase 2 clinical trials.
The Vice President, CMC is responsible for translating the corporate strategy into supportive strategies for global pharmaceutical manufacturing, packaging, supply chain, logistics and quality control (including process development, analytical development, technology transfer, validation, etc.) from early-mid stage product development through global manufacturing for commercial products. S/he oversees and provides technical leadership, strategic direction, risk assessment, and oversight for successful long-range planning and execution across all supporting functions
S/he leads assessments and analyses resulting in recommendations for contract manufacturing organization (CMO) qualification and negotiations that are consistent with and supportive of the global strategic plan and translation of strategy into an executable series of pharmaceutical manufacturing plans and quality control systems to ensure deliverables meet approved budgets, timelines and adhere to all international and national laws, guidelines and required quality control standards. The position has ultimate responsibility for the company’s strategy and oversight of supply chain/manufacturing and management of all technical operations activities to deliver products to clinical trials and/or market within defined regulatory, legal, quality and cost standards.
The ideal candidate will be a seasoned pharma/biotech executive with an outstanding record of accomplishment in R&D and commercial manufacturing of biologics, quality, supply chain management and logistics and with experience in the global submission and maintenance of CMC sections of regulatory (BLA) filings. Candidates will have previously worked on biologics CMC development programs that have been filed and approved for registration with the FDA and other global regulatory bodies.
This is an outstanding opportunity to serve as a driving force in building and expanding AnaptysBio’s pharmaceutical development and manufacturing organizations, and one that will provide broad business leadership challenge, accountability and impact for the successful candidate.
The successful candidate will have a strong record of accomplishments and successful leadership experience in biologics drug development and commercial drug product manufacturing, preferably with experience in a biotechnology company that has scaled from early-stage product development to commercial or near commercial-stage. S/he should have a track record of establishing a global commercial product supply chain and having had successful interactions with the regulatory agencies, as demonstrated by timely global CMC submissions, approvals and clinical and commercial supply of pharmaceutical compounds, specifically biologics drugs. B.S is required. PhD preferred.
• Position may require occasional evening and/or weekend commitment
• Position may require domestic and international travel (between 20 to 40%) (after COVID19 restrictions are lifted)