Senior Manager, Drug Substance
About The Position
As a Senior Manager, Drug Substance, you will provide oversight of project teams at CDMOs working on the development and production of intermediates and APIs for all stages of clinical development. The successful candidate will provide oversight for chemical process development and manufacturing. If required, he or she will oversee the transfer of processes or changes required within/between Rhythm contract manufacturing partners. He or she will ensure that processes, materials, and equipment for the manufacture of Drug Substance and intermediates are suitable for the stage of clinical development and adhere to regulatory requirements. He or she will ensure that contract manufacturers comply with appropriate manufacturing procedures, including any investigations, deviations, and changes required via Change Controls.
Requirements
- B.S./ M.S in Chemistry with at least 6+ years’ experience working with small molecule Drug Substances.
- Extensive experience in process chemistry development, scale-up, tech transfer and process characterizations.
- Thorough understanding of cGMP requirements for pharmaceutical products.
- Demonstrated experience with managing project teams, CDMOs and other vendors.
- Ability to work independently in a fast-paced dynamic environment.
- Strong analytical, organizational and decision-making skills.
- Excellent communication skills, both written and verbal.
- Deep understanding of small molecule drug development; understanding of how CMC integrates and partners with associated functional areas such as Quality, Preclinical, Clinical, Regulatory, and Intellectual Property Protection.
- Demonstrated ability to make sound, risk-based scientific and business decisions in ambiguous, fast-paced development environments.
- Ability to conduct, manage and communicate risk assessments.
Responsibilities
- Oversee CDMO team(s) in the scale-up of advanced chemical intermediates and APIs for GLP studies as well as early and late-stage GMP clinical studies.
- Collaborate with CDMOs to address process chemistry challenges and develop manufacturing processes that are scalable, safe, and cost-effective.
- Perform route scouting and development activities for small molecule Drug Substances.
- Assist with technology transfers of Drug Substances from one CDMO supplier to new suppliers.
- Review and approve manufacturing batch records.
- Assist with closing out supplier deviations and investigations.
- Write and review Drug Substance related technical documents.
Benefits
- discretionary annual bonus
- restricted stock units
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What This Job Offers
Job Type
Full-time
Career Level
Senior
