Opportunity OverviewAs a Senior Manager, Drug Substance you will provide oversight of project teams at CDMO's working on development and production of intermediates and API's 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 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.
Responsibilities and Duties- 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.
Qualifications and Skills- 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.
This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.
The expected salary range for this position is $135,000 - $215,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.
