Senior Director, Head of CMC

Cambridge, MA

ABOUT US

Aera Therapeutics was founded by a world-class team of scientists, investors, and company builders with a shared vision to unlock the potential of genetic medicines across a broad range of modalities and therapeutic areas. We strive for excellence and an industry-leading position in our chosen delivery platforms, while aggressively hunting for opportunities where enabling delivery technologies can unlock applications of high, unmet medical need.

Aera has two multiple proprietary delivery platforms including – targeted lipid nanoparticles (tLNPs), antibody oligonucleotide conjugates (AOCs) and protein nanoparticles (PNPs), – that are being developed to enable next-generation genetic medicines across a range of therapeutic modalities and disease areas. These platforms have the potential to overcome the limitations of today’s delivery technologies and expand the application of genetic medicines.

How will your role make an impact at Aera Therapeutics? We are looking for an experienced Senior Director, CMC to lead all Chemistry, Manufacturing, and Controls (CMC) activities related to our delivery programs. You will manage external Contract Development and Manufacturing Organizations (CDMOs), ensuring compliance with regulatory requirements, and driving the successful production of Aera's programs to support clinical development. You will report to the Senior Vice President, Operations and work onsite in our Cambridge, MA office.

You will:

External Manufacturing

• Manage relationships with global CDMOs to ensure the efficient and high-quality production.
• Oversee technology transfer, process development, scale-up, and manufacturing at external sites.
• Ensure continuity of supply and risk mitigation strategies for clinical trial materials and future commercialization.
• Establish and maintain contracts, quality agreements, and oversight frameworks with external partners.

CMC Strategy & Execution

• Define and execute the CMC strategy for programs from preclinical through Phase III
• Lead process development and optimization efforts to enhance product quality, consistency, and scalability.
• Collaborate with function teams (Research, Regulatory, Clinical, Analytical) to ensure agreement of manufacturing strategies with drug development goals.

Regulatory Compliance

• Ensure all manufacturing activities comply with global regulatory requirements (FDA, MHRA, EMA), cGMP guidelines, and industry best practices.
• Author and review CMC-related sections of regulatory submissions.
• Serve as an important CMC representative in regulatory interactions and inspections. Technical Leadership Innovation
• Identify and implement innovative solutions to improve manufacturing processes and reduce costs
• Provide technical expertise and troubleshooting support to resolve manufacturing and CMC challenges.

Project Management

• Lead CMC meeting agendas and ensure distribution of minutes/actions
• Track actions (internal and external) and project status updates
• Track decisions, risks and mitigation strategies to demonstrate project monitoring and progress
• Build presentations/summary reports for the leadership team

Qualifications:

• Ph.D., M.S., or B.S. in a scientific/engineering discipline with 10+ years of experience in biologics manufacturing. Must have prior experience with LNPs and mRNA. Experience with oligonucleotide-based drugs
• Experience managing external manufacturing and CMC operations in a biotech or pharmaceutical setting
• Hands-on experience with process development, scale-up, and GMP manufacturing of viral-based therapies
• Experience with global regulatory requirements for biologics manufacturing
• Experience in authoring CMC sections of regulatory submissions and participating in health authority interactions
• Strong experience and knowledge of cGMP manufacturing requirements
• Support budgeting, planning, and forecasting for drug product-related activities.
• Commitment to our Core Values: Respect, Integrity, Excellence, Impact

Benefits:

• Healthcare
• 401K
• PTO
• Commuting subsidy
• Parental leave

Aera Therapeutics is committed to providing equal employment opportunities by recruiting, hiring, training and promoting applicants and employees without regard to race, color, religion, creed, national origin, sex, age, ancestry, sexual orientation, genetics, pregnancy, marital status, familial status, victim of domestic violence status, gender identity/expression, disability, handicap, military obligations, veteran status or any other category protected by federal, state or local laws.