Manager/Senior Manager Drug Product Development and Manufacturing
The Manager/Senior Manager is responsible for supporting the execution of global CMC development and manufacturing objectives to ensure the timely attainment of high-quality products in sufficient quantities. This position manages and provides technical oversight for internal and external efforts to support successful planning and executing of assigned Chemistry, Manufacturing and Controls (CMC) and Quality activities associated with Drug Products (DP), Analytical Development, Validation, Technology Transfer, Supply Chain and Logistics including CMC Regulatory matters, from pre-clinical through commercialization. These are to ensure DP processes are manufactured in compliance with all regulations and guidelines to support preclinical and clinical studies as well as future commercial activities.
- Provide technical suggestions for development, manufacturing, and analytical methods at CMOs to ensure effective ongoing manufacturing of DP to support preclinical, clinical and commercialization meeting quality standards of Global Health Authority Regulations as well as regional requirements and ICH
- Support functional efforts to optimize existing manufacturing processes and to solve complex manufacturing issues in an expeditious
- Ensure that potential manufacturing risks are effectively identified, communicated, and
- Support the oversight of the development and execution of process improvements and scaleup efforts and may supervise CMOs in implementing
- Support the evaluation and introduction of new manufacturing processes that provide cost savings or commercial advantage.
- Recommend sites for manufacture of drug products with the goal of reducing manufacturing risks, costs and improve quality.
- Bring knowledge of manufacturing processes utilized by the pharmaceutical
- Support company goals and interests are fully integrated and represented in contract Manufacturing Site
- Support the development of Quality System to establish, implement, maintain, and document appropriate quality standards for development and production of DPs including the establishment of specifications and progressively tightening these specifications with production capabilities and the advancement of the program from preclinical through clinical development and commercialization.
- Support Regulatory department to prepare CMC sections for regulatory submissions, as well as CMC responses to regulatory agency questions/correspondence.
- Prepare technical reports to support regulatory submissions and future process development
- Review technical documentation, including technology transfer protocols, validation protocols, technical reports, and manufacturing information to ensure conformance with regulations and existing regulatory
- Provide support or oversee the preparation of DP formulations needed to support in-house animal studies.
Education and Experience Requirements:
- PhD with 6+ years’ or Bachelor/master’s degree with 10+ years’ experience in pharmaceutical Technical Operations and Manufacturing.
- Solid knowledge of cGMP for drug
- Experience in development and commercial manufacture of small molecule drugs.
- Good written and verbal communication
- High ethical standards, good judgment, and personal/professional integrity and proven discretion in handling proprietary information.
- Ability to thrive in a fast-paced, hands-on research and development
- Team player with a passion to work closely with others while maintaining an entrepreneurial, self-starter
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.