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Location: New Haven, CT (Northeast Preferred). This will be a hybrid position with at least 1x/month in person to New Haven, CT HQ.

Position Summary:

The Associate Director, Drug Substance Manufacturing will be responsible for providing oversight and management of external manufacturing collaborations, including scheduling and planning. This person will develop and execute the strategy for drug substance manufacture including commercial launch and supply. They will be responsible for the successful technical transfer, validation, and clinical and commercial manufacturing activities at Invivyd’s CDMO partners to ensure on-time delivery of cGMP drug substance.

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

Requirements:

• 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. 

#LI-Hybrid