Associate Director, Drug Substance Process Development

Invivyd•New Haven, CT

5h•Hybrid

About The Position

While the candidate brings strong scientific capability and experience in platform development, their background is primarily focused on early-stage CMC and discovery/preclinical work. 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, which were not sufficiently represented in the candidate’s background. Additionally, the role requires meaningful experience with small- and large-scale downstream processing equipment, which also appears limited.

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

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