Associate Director, External Manufacturing & Process DevelopmentCambridge, MAHow will your role make an impact at Aera Therapeutics? Aera 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 ensuring scalable, efficient, robust, and timely GMP manufacturing in compliance with regulatory requirements. You will report to the Vice President, Head of CMC, and work onsite 4-5 days per week.
You will:- 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.
- Serve as the Technical Lead for vendor qualification and audit activities.
- 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.
- Previous authorship of regulatory submissions with FDA, MHRA, and EMA. Experience with NMPA filings is a plus.
- Ability to travel internationally (~20%).
- Commitment to our Core Values: Respect, Integrity, Excellence, Impact
The approximate salary range for this role is $174,000 - $194,000.
Our salary ranges are determined by job scope, level, and location. The range displayed on this job posting reflects the minimum and maximum target for new hire salaries for the position as posted. Within the range, individual pay is determined by a variety of factors, including job-related skills, experience, relevant education or training, and business need. In addition to the base salary, eligible employees will have an opportunity to participate in an annual cash bonus, equity incentives, and a robust benefits offering that includes health insurance, 401k retirement plan with company match, paid sick and vacation time, life and disability insurance, and commuting expense reimbursement.
