Senior Director, CMC will lead the development and execution of the CMC strategy. Reporting to the SVP, Technical Operations, this individual will provide project management and CMC experience to ensure CMC activities are executed in alignment with the integrated product development plan for development and clinical stage programs at Beam Therapeutics. This individual will manage the CMC team and work with cross-functional stakeholders in Technical Operations, Pharmaceutical Sciences and Quality to drive alignment and achievement of CMC development and manufacturing milestones in accordance with program timelines.
- Develop and implement comprehensive strategies to manufacture drug substance / drug product, and assume all aspects of process / analytical development, manufacturing, and quality control.
- Lead CRO / CMO strategy including selection and contract negotiation, ongoing troubleshooting, data analysis and interpretation.
- Work across functional groups in identifying issues that may delay timelines, providing solutions to difficult technical/functional issues associated with specific projects, as well as support the resolution of issues that arise.
- Maintaining program-related CMC-specific documentation, including, but not limited to, program plans, timelines, and budget
- Serve as SME in the areas of non-clinical CMC to both preclinical and development project teams.
- Support, prepare, and review applicable CMC portions of regulatory filings to regulatory authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and submission of marketing applications.
- Managing technology transfer team meeting operations (planning agendas, scheduling meetings, preparing minutes, and following-up with team members on critical action items).
- Coordinating internal program timelines and priorities with your counterparts at Contract Manufacturing Organizations.
- Proactively identifying knowledge gaps and risks, and work with the teams and team leaders to develop mitigation plans.
- Facilitating internal CMC decision-making processes and preparing regular updates for senior management and Program Leaders.
- Strong knowledge of GMP regulations as well as familiarity with regulatory requirements surrounding import and distributions.
- PhD preferred in a relevant area of study, with a minimum of 10 years of relevant experience in pharmaceutical GMP development and process chemistry.
- Strong foundation in chemistry, materials science, pharmaceutical sciences or chemical engineering required.
- Drug product development experience is preferred.
- Ability to provide hands-on problem-solving skills and strong critical thinking.
- Proven experience as a direct manager of people or external teams, and as a leader for milestone and budget-driven projects.
- Strong background in modern synthetic organic chemistry and drug development processes required.
- The desire to work in a fast-paced, timeline-driven environment, and ability to manage outsourced projects with external vendor.
- Outstanding written and verbal communication skills, with the ability to convey CMC strategies and results to a varied audience.