Senior Vice President, Technical Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervise the Technical Operations team, which encompasses CMC Development, Manufacturing (drug substance, drug product), Supply Chain and Distribution, and Quality Control.

• Formulate and implement Invivyd’s comprehensive clinical and commercial manufacturing strategy, covering planning, contracting, CDMO management, and execution, including supply and distribution.

• Oversee CMC development initiatives, including process, analytical, and formulation activities for Invivyd’s clinical and commercial product candidates.

• Provide technical operations oversight to guide strategic decision-making.

• Lead interactions with CDMOs and other contract services essential for executing the Technical Operations plan and strategy.

• Collaborate with other functional areas to support and communicate the overarching corporate strategy.

• Work closely with Regulatory Affairs to develop and convey CMC regulatory strategies aligned with the company’s goals.

• Represent Invivyd to external stakeholders, including regulatory agencies and biotechnology industry collaborators/partners.

• Foster strong working relationships across departments to ensure transparency and enhance communication.

• Guide the team in planning for cross-functional transitions.

⛳️ Requirements

• PhD or equivalent in Biochemical Engineering, Biochemistry, or a related field with experience in biologics (including antibody)-based development and manufacturing.

• A minimum of 15 years of experience in the pharmaceutical and/or biotechnology sector, with startup experience considered an advantage.

• Several years of management experience leading a collaborative team.

• Demonstrated success in overseeing a department, including staffing and budget management.

• Proficient in biologics development, including process, analytical, and formulation development activities.

• Required experience in both early and late clinical stage CMC development, including validation and commercialization.

• Familiarity with CDMOs, including selection and management; knowledge of cGMPs is essential.

• Experience in a development organization, with integration across research, non-clinical, and clinical teams being desirable.

• Essential CMC regulatory experience, including IND / IMPD filings and BLA submissions.

• Must possess exceptional leadership and interpersonal skills; should demonstrate proven effectiveness as a team player who can establish credibility and confidence both internally and externally.

• Must be driven by science and data.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and career advancement.

• Flexible work environment and work-life balance initiatives.

• Collaborative culture that values innovation and teamwork.