Senior Manager, Drug Substance
$135k - $215kFull-time
Rhythm Pharmaceuticals
Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview
As 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
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. At Rhythm our core values are:
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview
As 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.
- 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.
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. At Rhythm our core values are:
- We are committed to advancing scientific understanding to improve patients’ lives
- We are inspired to tackle tough challenges and have the courage to ask bold questions
- We are eager to learn and adapt
- We believe collaboration and ownership are foundational for our success
- We value the unique contribution each individual brings to furthering our mission
Vacancy posted a month ago
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