Associate Director, Drug Substance Manufacturing

Invivyd, Inc.•New Haven, CT

6d•Hybrid

About The Position

There are more than 9 million immunocompromised people in the United States. Almost half a million of those represent a population that are moderately to severely immunocompromised and at highest risk for severe COVID-19, including stem cell and solid organ transplant patients as well as those with hematologic cancers. At Invivyd, Inc., we take those numbers very seriously and we come to work each day on a mission to deliver protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024 , Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. In October 2025 , the FDA cleared the company's Investigational New Drug (IND) application and provided feedback to advance the company's REVOLUTION clinical program, Invivyd's development program for VYD2311, a vaccine alternative monoclonal antibody being investigated for the prevention of COVID-19. Be part of making a difference. Be part of Invivyd. Location: New Haven, CT (Northeast Preferred). This will be a hybrid position with at least 1x/month in person to New Haven, CT HQ. Position Summary: The Associate Director, Drug Substance Manufacturing will be responsible for providing oversight and management of external manufacturing collaborations, including scheduling and planning. This person will develop and execute the strategy for drug substance manufacture including commercial launch and supply. They will be responsible for the successful technical transfer, validation, and clinical and commercial manufacturing activities at Invivyd's CDMO partners to ensure on-time delivery of cGMP drug substance.

Requirements

M.S. or Ph.D. in Biochemistry or Biochemical Engineering or a related scientific field with 10-15 years of industry experience
Experience in biologics manufacturing, scale-up, late-stage validation, and process tech transfer
Experience working with biologics manufacturing and development, preferably monoclonal antibodies
Experience working with and successful management of CDMOs
Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company
Expert knowledge of cGMPs, ICH guidelines, FDA and EMA/CHMP (and other international) regulatory requirements
Strong communication, organization, and multitasking skills are needed for this role.
Highly collaborative style and ability to effectively communicate and identify key points of program integration is needed
A creative problem solver with the proven ability to work independently and collaboratively in a fast-paced, results-oriented and dynamic start-up environment
This position will have up to 10% travel (domestic/international) and require occasional travel to our corporate headquarters in New Haven, CT.

Responsibilities

Provide oversight of facility tech transfer, validation, and scale-up activities
Critically evaluate process and analytical data to identify and resolve key challenges during development
Manage drug substance validation activities ensuring compliance with regulatory expectations
Provide relevant information for drug substance sections for regulatory filings (including INDs, IMPDs, briefing packages or other regulatory dossiers)
Identify and mitigate potential regulatory and quality risks for the drug substance manufacture and subsequent resolution of compliance and quality issues
Develop relationships with external parties (CROs, CMOs, RM suppliers, consultants, etc.) and stay current on industry trends and practices
Ensure adequate documentation processes and systems are available and followed for drug substance manufacturing, testing and release (SOPs / Protocols review /approval)
Support technical transfer and manage / oversee transfer activities for drug substance activities.
Work closely with counterparts in Drug Product manufacturing and supply chain to ensure sufficient drug availability to meet program needs
Support drug substance supply planning, for commercial product and development projects with our CDMOs
Work closely with other members of the Technical Operations team to drive planning and execution of projects, coordinating with internal cross-functional teams and external CDMOs.
Identify CMC project critical path and propose risk mitigations to keep programs on track
Collaborate with quality function to make sure supply is secured and de-risked
Manage process monitoring and data management systems to ensure successful manufacturing operations