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Invivyd · 6 hours ago

Associate Director, Drug Substance Manufacturing

New Haven, CT (Northeast Preferred)

Full-time

Hybrid

Lead/Staff, Director/Executive

10+ years exp

Invivyd is dedicated to delivering protection from serious viral infectious diseases, including COVID-19. The Associate Director, Drug Substance Manufacturing will oversee external manufacturing collaborations, develop strategies for drug substance manufacture, and ensure compliance with regulatory expectations while managing technical transfers and manufacturing activities.

BiotechnologyPharmaceuticalTherapeutics

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

Qualification

Biologics manufacturingProcess tech transferCGMP knowledgeRegulatory complianceCDMO managementMultitasking skillsCommunicationCreative problem solving

Required

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