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Vice President, CMC

Employer
AnaptysBio, Inc.
Location
San Diego, CA
Start date
Jul 21, 2021

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Discipline
Science/R&D, CMC
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Biotech Beach

Job Details

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.  

Requirements

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.

Other Information

• 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)

Company

AnaptysBio is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics. We are developing immune cell modulators, including two checkpoint agonists in clinical-stage development, for autoimmune and inflammatory disease: rosnilimab, our PD-1 agonist program in a Phase 2 trial for the treatment of moderate-to-severe rheumatoid arthritis; and ANB032, our BTLA agonist program, currently in a Phase 2b trial for the treatment of moderate-to-severe atopic dermatitis. Our preclinical immune cell modulator portfolio includes ANB033, an anti-CD122 antagonist antibody for the treatment of autoimmune and inflammatory diseases. In addition, AnaptysBio has developed two cytokine antagonists available for out-licensing: imsidolimab, an anti-IL-36R antagonist, in Phase 3 for the treatment of generalized pustular psoriasis, or GPP, and etokimab, an anti-IL-33 antagonist for the treatment of respiratory disorders that is Phase 2/3 ready. AnaptysBio has also discovered multiple therapeutic antibodies licensed to GSK in a financial collaboration for immune-oncology, including an anti-PD-1 antagonist antibody (Jemperli (dostarlimab-gxly)), an anti-TIM-3 antagonist antibody (cobolimab, GSK4069889) and an anti-LAG-3 antagonist antibody (GSK4074386).

Our corporate vision is to transform patient health by delivering innovative immunology therapeutics. Find out more about us by following us on Twitter.

 

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Company info
Website
Phone
858-362-6295
Location
10770 Wateridge Circle
Suite 210
San Diego
California
92121
United States

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