Associate Director, Drug Substance Process Development

Invivyd

4 days ago

4.2 on Glassdoor

New Haven, CT

Hybrid

Full Time

Senior

0 applicants

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About this role

A senior role in drug substance process development for biologics, focusing on downstream purification and integration with GMP manufacturing operations. The role involves technical leadership, process scale-up, technology transfer, and collaboration with external manufacturing partners.

Skills

Qualifications

BS/MS in Chemical Engineering, Biochemical Engineering, Pharmaceutical Engineering, or related scientific discipline10–15 years of experience in biopharmaceutical or biotechnology industryExperience in drug substance process development for biologics (preferably monoclonal antibodies)Strong knowledge of cGMP principles, ICH guidelines (Q8–Q11), and global regulatory expectations (FDA, EMA/CHMP)

About Invivyd

invivyd.com

Invivyd is a biotechnology company focused on developing antibody-based therapies to address evolving viral threats. Its mission is to rapidly and continually deliver antibody treatments that keep pace with viral evolution using platform-driven discovery, optimization, and deployment. Invivyd builds a responsive pipeline and manufacturing approach to enable fast updates and distribution as new variants emerge. The company positions its work to strengthen public-health preparedness by providing adaptable therapeutic options.