Associate Director, Drug Substance Process Development

Location: New Haven (Northeast Preferred)

Position summary:

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.

Responsibilities:

• Provide technical leadership and oversight for drug substance process development activities, including process design, scale-up strategy, and technology transfer to CMOs
• Serve as a subject matter expert for upstream and downstream process development, with particular emphasis on downstream purification strategy, process robustness, and scalability
• Lead the design and execution of process characterization, process performance qualification (PPQ)-enabling studies, comparability assessments, and impurity control strategies to support clinical and commercial readiness
• Define and translate process requirements into development reports, control strategies, and technology transfer packages to enable successful execution at external manufacturing partners
• Collaborate with CMOs to ensure effective process transfer, scale-up, and process validation readiness, providing scientific and technical guidance rather than direct manufacturing oversight
• Critically evaluate process and analytical data to identify risks, optimize performance, and resolve technical challenges throughout development
• Develop and maintain strong relationships with external partners (CMOs, CROs, raw material suppliers, and consultants), ensuring alignment on development strategy and execution
• Partner cross-functionally with Analytical Development, Quality, Regulatory, and Supply Chain to align on control strategy, specifications, and overall CMC strategy
• Contribute to CMC regulatory submissions, including authoring and reviewing drug substance sections (INDs/IMPDs, BLAs/MAAs, and supporting documentation)
• Identify program risks and critical path activities, and proactively develop mitigation strategies to ensure successful progression of development programs
• Ensure that processes are designed for cGMP compliance and are aligned with FDA and EMA expectations, with clear line of sight to commercialization

Requirements:

• 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

Pay Range

$152,000 - $202,000

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/.