Associate Director, Drug Substance Process Development

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.

This role reports to the Head of Process Development and Manufacturing and is responsible for oversight and execution of drug substance process development activities at Invivyd’s Contract Manufacturing Organizations (CMOs), including technology transfer, process scale-up, process characterization, process validation, and support of clinical and commercial manufacturing supply.

As such, the position requires deep, hands-on expertise in drug substance development, particularly in downstream purification process development and its integration with GMP manufacturing operations. It also requires demonstrated experience in external manufacturing oversight, technology transfer, and late-stage/commercial readiness.

Additionally, the role requires meaningful experience with small- and large-scale downstream processing equipment.

• →BS/MS in Chemical Engineering, Biochemical Engineering, Pharmaceutical Engineering, or related scientific discipline, with 10–15 years of experience in biopharmaceutical or biotechnology industry, including process development, scale-up, and technology transfer
• →Demonstrated experience in drug substance process development for biologics (preferably monoclonal antibodies), with strong emphasis on downstream purification development, including chromatography, filtration, and viral clearance strategies across small- and large-scale systems
• →Proven track record in process scale-up, process characterization, and development of control strategies to support late-stage clinical and commercial readiness
• →Extensive experience leading and supporting technology transfer to CDMOs, including preparation of technical packages and ensuring successful process implementation at external partners
• →Demonstrated ability to effectively manage and influence CDMOs from a development perspective, ensuring alignment on process performance, timelines, and deliverables
• →Strong knowledge of cGMP principles, ICH guidelines (Q8–Q11), and global regulatory expectations (FDA, EMA/CHMP) as they relate to process development and commercialization
• →Experience supporting CMC regulatory filings, including authoring or reviewing drug substance sections for INDs/IMPDs and BLAs/MAAs
• →Highly motivated, decisive, and results-oriented, with the ability to drive development programs in a fast-paced, matrixed environment
• →Strong communication and leadership skills, with demonstrated ability to collaborate cross-functionally and communicate effectively with external partners, senior leadership, and stakeholders
• →Proven problem-solving capability with the ability to analyze complex process data, identify risks, and implement effective mitigation strategies
• →Willingness to travel (up to ~20%) to support technology transfer activities and key development milestones at CDMOs
• →This role will require the ability to work in a hybrid capacity, once per week in the HQ office

The pay range represents the expected full-time base salary for this role at the time of posting. Actual base pay will be determined based on a variety of factors, including relevant experience, skills, and education. In addition to base pay, this role is eligible for both an annual short-term incentive (e.g., bonus or sales incentive) and an annual long-term incentive (e.g., equity), reflecting our commitment to rewarding strong performance and long-term impact. Learn more about our total rewards by visiting https://www.invivyd.com/careers/.