Senior Vice President, Technical Operations
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Job Description
Senior Vice President leading technical operations at Invivyd, an antibody company protecting immunocompromised patients from viral diseases. Overseeing CMC, manufacturing, supply chain, quality, and regulatory strategy.
Responsibilities:
- Oversee the Technical Operations group including CMC Development, Manufacturing (drug substance, drug product), Supply Chain and Distribution, and Quality Control
- Develop and execute Invivyd’s overall clinical and commercial manufacturing strategy including planning, contracting, CDMO oversight, and execution including supply and distribution
- Direct CMC development activities including process, analytical and formulation activities for Invivyd’s clinical and commercial product candidates
- Provide technical operations oversight to strategic decision making
- Lead interactions with CDMOs and other contract services needed to execute the Technical Operations plan and strategy
- Provide support and work with other functional areas to develop and communicate the overall corporate strategy
- In close coordination with Regulatory Affairs, develop and communicate CMC regulatory strategies to fit the company’s objectives
- Represent Invivyd to external audiences, including regulatory authorities and biotechnology industry collaborators/partners
- Build strong working relationships across departments to ensure transparency and to facilitate communication
- Lead the team through planning for cross-functional transitions
Requirements:
- PhD or equivalent in Biochemical Engineering, Biochemistry or equivalent with biologics (including antibody)-based development and manufacturing experience
- 15 years minimum experience in pharmaceutical and/or biotechnology industry, start-up experience a plus
- Multiple years of management experience leading a collaborative team
- Proven success record in overseeing a department, including staffing and budget activities
- Experience with biologics development including process, analytical, and formulation development activities
- Experience with both early and late clinical stage CMC development required, including validation and commercialization experience
- Experience with CDMOs including selection and management; knowledge of cGMPs essential
- Experience in a development organization including integration with research, non-clinical, and clinical groups is desirable
- CMC regulatory experience essential, including IND / IMPD filings and BLA submissions
- Must have excellent leadership and interpersonal skills; should have proven skills as an effective team player who can engender credibility and confidence within and outside the company
- Must be science- and data-driven
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