Responsibilities
- 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.
- Manage CMC leads and/or lead key matrix CMC Asset teams when needed.
- Author and/or review CMC sections of IND, NDA, and global regulatory submissions (Module 3).
- Ensure compliance with cGMP, ICH guidelines, and FDA CMC requirements.
- Lead phase-appropriate process development, optimization, and validation activities.
- Recommend scientifically rigorous, phase-appropriate, risk management-based solutions to complex technical challenges.
- Develop impurity control strategies and ensure processes meet global regulatory standards.
- Serve as the technical subject matter expert (SME) and process owner when needed.
- Drive successful technology transfers and monitor clinical manufacturing operations, including batch record review and data trending.
- Lead and mentor a team of technical professionals, fostering a culture of collaboration, accountability, and continuous improvement.
- Provide career development guidance, performance feedback, and succession planning for team members.
- Allocate resources effectively across projects and ensure alignment with organizational priorities.
- Promote technical excellence through coaching, training, and knowledge-sharing initiatives.
- Drive engagement and retention by creating an inclusive and supportive work environment.
Work Arrangement
Hybrid
Team
Reports to: Senior Vice President, Global CMC and External Manufacturing
Additional Information
- Ability to travel internationally up to 10%.
- Candidates must be able to attend meetings at the office in Cambridge, MA on a regular basis.
- Preference given to candidates who reside in the New England region.
- When working remotely, must have access to a private work setting with reliable internet, phone, and video conferencing capability.
