AffyImmune Therapeutics (“Affy”), a clinical stage biotechnology company focused on creating technologies that expand the utility and improve the safety of cell-based immunotherapy for cancer, is seeking a Director of CMC to oversee and recommend improvements to the company’s manufacturing processes.

Working alongside our Chief Operating Officer, you will join a small team at a dynamic startup. You will collaborate within and outside the organization to help us meet our manufacturing needs. With your superb communication skills, attention to detail, and flexibility, you will leave an indelible mark on Affy.

Location: Natick, MA

Responsibilities:
• Lead and manage regulatory CMC activities to support global expansion for key oncology products, developing strategies for appropriate filings.
• Oversee start-up and technology transfer to clinical manufacturing site(s)
• Provide input to process development teams for developing GMP manufacturing processes
• As part of the manufacturing team, develop strategies for clinical supply for future trials and product launchProvide timely regulatory and documentation review, support, and guidance to Affy departments, projects, and development teams.
• Create and implement development and post-approval regulatory strategies for Affy pipeline assets.
• Prepare, review, and/or edit cGMP batch records, CMC regulatory and quality documents.
• Ensure regulatory authority submissions are complete and compliant with applicable requirements.
• Write and review technical documentation and recommend changes as appropriate to ensure regulatory compliance and conformance with existing regulatory filings and requirements.
• Research and analyze regulatory information and maintain current regulatory knowledge.
• Oversee implementation of manufacturing process development and improvements
• Identify and mitigate risks in manufacturing operations
• Investigate production variances and deviates to identify root causes and document corrective and preventive actions.
• Establish and lead teams to source, vet, qualify, and implement manufacturing technologies including equipment, supplies, infrastructure, and IT.
• Other duties as assigned.

Qualifications:
● Bachelor of Science with a major in life sciences (biology, chemistry, biochemistry, immunology, etc.) required. Advanced degree (M.S., Ph.D.) preferred.
● Minimum 7 years of pharmaceutical regulatory CMC experience in the US. Small biotech experience, especially with cellular and/or gene therapies, preferred but not required.
● Understanding of chimeric antigen receptor (CAR) based T-cells, specifically T cell activation, T cell-mediated lysis and T cell exhaustion.
● Thorough working knowledge across a broad range of drug development areas, including experience preparing CMC sections of Investigational New Drug (INDs) applications and New Drug Applications (NDAs).
● Experience preparing quality modules of INDs, IMPDs, NDAs, MAAs, and supportive amendments/variations.
● Minimum of 2 years supervisory experience and leading teams in a matrixed and milestone-driven environment
● Hands on experience with drug product manufacturing scale up/scale out, technology transfer, and process optimization.
● Strong knowledge and understanding of cGMP regulations and FDA guidance applicable to cell therapy manufacturing.
● Must demonstrate a firm commitment to achieving Affy’s objectives while maintaining the highest ethical, regulatory, and scientific standards.
● Highly organized, collaborative, and motivated in a fast-paced startup environment.

This is a salaried, benefit-eligible position.