Our valued client is a clinical-stage biotech company in the field of targeted protein degradation (TPD). They are looking for a talented Scientist to join their team as the Director of Drug Substance development. In this role, you will lead the Drug Substance strategic, tactical, and scientific deliverables for one of our key programs and serve as the process chemistry representative on our integrated CMC team for late-stage (post Phase 1) development and manufacturing. You will use data and risk-based approaches to commercial route and process innovation and selection by incorporating principles of green chemistry and process safety in concert with regulatory requirements. You will also develop clinical supply manufacturing strategy, integrated with phase and regulatory appropriate route and process improvements. This role will involve managing and coordinating outsourcing efforts at external CROs and CDMOs to ensure high quality and on-time execution and you will serve as technology lead for process technology transfers. You will also collaborate with Drug Product and Analytical colleagues to ensure the Drug Substance physical attributes are understood and controlled, and prepare for and execute process characterization with cross-functional colleagues, utilizing Quality by Design principles.
What skills and experience you’ll bring:
- Ph.D. in Chemistry or Chemical Engineering with at least 10 years’ or B.S./ M.S. in Chemistry or Chemical Engineering with at least 15 years’ experience in Drug Substance Development.
- Experience with:
- Bringing post First in Human small molecule assets through mid-phase to commercialization.
- Serving as the Drug Substance lead on fully integrated Chemistry, Manufacturing, and Control (CMC) teams.
- Late-stage optimization, process characterization, registration, and validation.
- Building the Drug Substance data package for, and composition of a New Drug Application (NDA).
- Directing and managing CRO and CDMO partners.
- Deep understanding of small molecule drug development; understand how CMC disciplines integrate and partners with associated functional areas such as Risk Management and Quality, Drug Safety, Clinical, Regulatory, Intellectual Property Protection, and Contracts.
- In-depth familiarity with phase based GMPs and manufacturing compliance requirements, regulatory guidelines and expectations.
- Willingness and ability to work hands-on and with a sense of urgency in a fast-paced, agile environment.
- Ability to manage ambiguity, think critically, and make sound, risk-based scientific and business decisions when there is limited information.
- Ability to conduct, manage, and communicate risk assessments.
Please reach out to ftodd@stem-sourcing.com with any questions.
