Senior Vice President, Technical Operations

The role

The Senior Vice President, Technical Operations provides leadership and direction for the Technical Operations group. This person is responsible for the strategy, direction, and execution of technical initiatives across the organization.

What you will do

• Oversee the Technical Operations group including CMC Development, Manufacturing, Supply Chain and Distribution, and Quality Control
• Develop and execute Invivyd’s overall clinical and commercial manufacturing strategy
• Direct CMC development activities including process, analytical and formulation activities
• Provide technical operations oversight for strategic decision making
• Lead interactions with CDMOs and other contract services
• Provide support and work with other functional areas to develop and communicate the overall corporate strategy
• Develop and communicate CMC regulatory strategies in coordination with Regulatory Affairs
• Represent Invivyd to external audiences, including regulatory authorities and biotechnology industry collaborators/partners
• Build strong working relationships across departments
• Lead the team through planning for cross-functional transitions

Required qualifications

• PhD or equivalent in Biochemical Engineering, Biochemistry or equivalent
• Experience with biologics including antibody-based development and manufacturing
• 15 years minimum experience in pharmaceutical and/or biotechnology industry
• 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, including validation and commercialization experience
• Experience with CDMOs including selection and management
• Knowledge of cGMPs
• CMC regulatory experience, including IND / IMPD filings and BLA submissions
• Excellent leadership and interpersonal skills
• Science- and data-driven

Nice to have

• start-up experience is strongly preferred
• Experience in a development organization including integration with research, non-clinical, and clinical groups is desirable

About the company

Invivyd, Inc. works to deliver protection from serious viral infectious diseases using a proprietary integrated technology platform to create antibodies. The company has received FDA emergency use authorization for a monoclonal antibody and is advancing its REVOLUTION clinical program.