Associate Director, External Manufacturing

About the role

Aera Therapeutics is seeking an experienced Associate Director of External Manufacturing and Process Development to oversee technology transfer and outsourced manufacturing activities for Aera's lead development candidate (AERA-109) and pipeline programs. You will manage Contract Development and Manufacturing Organizations (CDMOs) and ensure scalable, efficient, robust, and timely GMP manufacturing in compliance with regulatory requirements.

Responsibilities

• Evaluate CDMO candidates for GMP manufacturing, prepare RFPs, review proposals, and perform technical assessments.
• Oversee technology transfer, process development, scale-up, and manufacturing at CDMO sites.
• Ensure all manufacturing activities comply with cGMP guidelines and industry best practices; draft and review manufacturing documentation (MBRs, BOMs, PFDs, executed batch records, etc); oversee GMP manufacturing campaigns.
• Provide technical expertise and troubleshooting support to resolve manufacturing and CMC challenges.
• Ensure continuity of supply and risk mitigation strategies for clinical trial materials; lead GOGs optimization.
• Author and review CMC sections of regulatory submissions.
• In partnership with QA, support Aera's internal Quality System and provide quality oversight of external GMP vendors.
• Manage noncompliance/deviation events and CAPAs.
• Maintain inspection readiness.
• In partnership with Program Management, track external manufacturing budget, project progress, decisions, and risks.
• Collaborate with R&D, Clinical, Quality, Regulatory, and Program Management to ensure alignment of manufacturing capabilities with overall development goals.
• Execute CMC activities to advance development programs to and through clinical development.

Qualifications

• Ph.D. in a scientific/engineering discipline with 8+ years of experience in process development and manufacturing for advanced modalities (or 10+ year of experience with a M.S. degree).
• Must have hands-on experience with process development, scale-up, and GMP manufacturing for biologics and mRNA (upstream and downstream).
• Prior experience LNPs, oligonucleotides, and bioconjugation is a plus.
• Demonstrated success managing fully outsourced external manufacturing and CMC operations.
• Strong understanding of GMP compliance principles and global regulatory requirements for biologics manufacturing.
• Experience with NMPA filings is a plus.
• Ability to travel internationally (~20%).
• Commitment to our Core Values: Respect, Integrity, Excellence, Impact.