Senior Vice President, Technical Operations

Invivyd•New Haven, CT

22h•Hybrid

About The Position

The Senior Vice President, Technical Operations will provide leadership and direction for Invivyd’s Technical Operations group. The SVP is responsible for strategy, direction, and execution of technical initiatives in partnership across the organization and provides oversight to the entire Technical Operations team.

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.
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.

Nice To Haves

Experience in a development organization including integration with research, non-clinical, and clinical groups is desirable.

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.