Senior Director, CMC

📋 Description

• Partner with Regulatory, Quality, Analytical Development, Supply Chain, and External Manufacturing teams to execute CMC strategies for drug development from early-phase through commercialization aligned with asset development plans.
• Foster effective teamwork and drive project execution. Proactively track critical path activities, anticipate risks, create contingency plans and decision-making exercises in collaboration with project teams.
• Provide guidance on timelines, budgets, and risk mitigation strategies.
• Evaluate new CDMOs to support tox and clinical material needs. Provide technical leadership for all due diligence and tech transfer projects.
• Travel to global manufacturing sites to support development operations and foster collaboration.
• Lead and mentor a team of technical professionals, fostering a culture of collaboration, accountability, and continuous improvement.

🎯 Requirements

• Advanced degree in chemistry, chemical engineering, or related field.
• A solid understanding of small molecule, RNA, and peptide/amino acid chemistries.
• At least 15 years of experience in technical process development from early through late phase. Prior process validation experience preferred.
• Expertise in developing phase-appropriate oligonucleotide and/or synthetic peptide manufacturing processes.
• Advanced knowledge of cGMP/GLP regulations, ICH guidelines, and FDA CMC requirements.
• A strong track record of successful global CMC submissions and approvals.
• Must be able to function independently, influence appropriate stakeholders, and build relationships internally and externally.
• Experience partnering with contract manufacturing organizations.

🎁 Benefits

• Remote work opportunities within the United States with regular meetings at Cambridge, MA.
• Flexible work arrangement with some in-person office presence required.
• Accommodations available for candidates who require them in the selection process.
• Inclusive and supportive work environment with commitment to equal opportunity.