Director/Sr. Director, Chemical Development and Manufacturing
Redwood City , CA /
Technical Operations [CMC/MFG & QC] /
Full Time Employee (FTE)
Biomea Fusion, Inc. is seeking Director/Senior Director, Chemical Development and Manufacturing who will be responsible for the process development and supply of small molecule drug substance (API) for all phases of clinical development (process research, scale-up, and process validation) and commercial launch activities. The candidate will be responsible for developing safe, efficient, and easily scalable drug substance processes for producing starting materials, intermediates, and drug substance (DS). All GMP aspects of the development projects are carried out by outsourcing to various contract research or manufacturing organizations (CRO/CMO). The candidate will serve as a liaison with various internal and external functional groups to ensure that high quality standards are met and appropriate documentation such as process development and scale-up reports including master batch records (MBR) are completed in a timely manner and that needed standard operating procedures (SOP’s) are written and followed. Candidates must possess advanced pharmaceutical organic chemistry skills combined with exceptional project management leadership, organization, and communication skills.
- For each molecule, develop an overall DS strategy, timelines, budgets, identify risks, prepare mitigations plans for all chemical process development from starting materials to completion of the DS for each manufacturing campaigns.
- Execute DS supply chain strategy to ensure there is sufficient DS for clinical supply. Lead continuous process improvement for campaign manufacturing for all stages of DS projects at the CMO.
- Actively manage development activities including scale up and technology transfer at the CMO.
- Develop a control strategy, identify critical process parameters, process acceptance ranges (PAR), normal operating ranges (NOR), and documents as the molecule advances to late stage.
- Select CMOs for new molecules and project-specific activities. Actively work to develop robust and optimal critical steps such as the crystallization and purification process for final DS step.
- Work with CM to identify source for starting materials and intermediates and develop plans for consistent and continuous supply.
- Derive origins of process impurities and steps for their control, work with the CMO and internal Analytical groups to conduct forced degradation studies. Work with CMO on synthesis or isolation of process impurities.
- Represent Chemical Development and Manufacturing at CMC meetings to provide assessments, evaluations, status, issues, and other relevant technical aspects of the corresponding program.
- Author and review appropriate CMC sections to support regulatory (IND, IMPD, NDA) submissions.
- Represent as the technical subject matter expert (SME) internally for troubleshooting process chemistry issues.
- Review and approve executed batch documents for drug substance manufacturing.
- Maintain process trend data to understand process changes.
- Interact with patent counsel in helping to draft patent applications for any new chemical processes, polymorph and salt form.
- Working with project teams to identify DS requirements, managing and optimizing aggressive project timelines, overseeing the development of technical solutions to ensure that DS processes can successfully manufacture quality DS.
- Supervise, mentor, and guide direct reports (e.g. PR&D Senior Scientists, Scientists, and Associate Scientists) to enable them to be productive contributors and facilitate their scientific and career growth.
Education and Experience Requirements
- PhD in Organic Chemistry or equivalent with >15 years of process development related experience in pharmaceutical industry; or MS in Organic Chemistry or equivalent with >20 years of process development related experience in the pharmaceutical industry.
- Thorough knowledge of process chemistry and scale-up with a proven track record in developing and implementing robust and efficient drug substance manufacturing processes across the Development continuum through Registration and up to commercial launch.
- Proven chemical development experience from early phase to late or commercial phases in compliant with US, EU and ICH Regulatory guidance. Demonstrated familiarity with QbD paradigms utilizing risk-based development tools to advance compounds aggressively through Development.
- Can effectively interface with internal and external scientific teams, and all levels of management, with a strong ability to lead through influence.
- Demonstrates strong analytical, written, and verbal communication skills. Possesses the ability to write clear and concise technical reports, presentations, and business correspondence.
- Ability to manage multiple chemical programs in alignment with business objectives, and then plan, organize, and oversee multiple independent development teams to execute accordingly. Ability to work independently in a fast-paced environment.
- Strong knowledge of analytical techniques (HPLC, GC, NMR, XRPD, DSC, KF, UV, LC-MS, PH meter).
- Experience handling technology transfers and good understanding on Contract and business terms.
- Ability to validate late-stage or commercial manufacturing DS processes and a proven track record in cGMP manufacturing.
- Experience in managing and support any internal Quality, Business partner or Regulatory GMP inspections.
Equal Employment Opportunity
At Biomea Fusion, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.