Sr. Manager CMC
Constellation seeks an experienced and highly motivated CMC/Analytical scientist to join its CMC team located in Cambridge, MA. The ideal candidate will have a strong background in analytical chemistry and other CMC disciplines such as chemistry, formulation, and manufacturing. Additionally, the successful candidate will have broad experience in the creation and execution of product development strategies to advance and support our small molecule portfolio from preclinical projects through late clinical development. Candidates who are enthusiastic team players and have a passion for playing a key role in the discovery and development of life-saving medicines are encouraged to apply.
- Work closely with the CMC Team to create and implement comprehensive strategies to drive CMC development of our programs and manufacture drug substance and drug product, to ensure a reliable clinical supply chain with well-managed risk
- Manage and drive development activities at CRO/CMOs in support of development and GMP manufacturing. Responsibilities include vendor selection and relationship management, project design, ongoing troubleshooting, data analysis, trending, and interpretation, and oversight of study report writing
- Interface with the Constellation Discovery Chemistry team to facilitate rapid, seamless optimization of development candidates into process development
- Develop and validate fit-for-purpose analytical methods and manufacturing controls for APIs and Drug Products to appropriate guidelines
- Manage the characterization and recertification of reference standards in support of product development and manufacturing
- Manage and oversee stability studies for API and Drug Product. Responsibilities include designing studies, reviewing/approving protocols and reports, tracking and trending data, and presentation of results
- Design and implement formulation strategies to enable toxicology and clinical development for oral routes of administration
- Interpret, effectively communicate and apply all relevant FDA, EMA and ICH guidelines
- Ensure submissions meet current regulatory standards. Author, review and approve CMC portions of study reports, manufacturing process documentation and regulatory filings (e.g. IND/CTA, IMPD, Investigator’s Brochure, CTD, etc.)
Qualifications and Required Experience:
- Advance Degree in Life Science Chemistry preferred, or M.S. with appropriate experience
- 7+ years of experience in the pharma/biotechnology industry
- Experience in GMP production, analytical method development and validation, material characterization, process development, scale-up engineering, and formulation development
- Demonstrated understanding of the drug development process from research through a commercial product including an understanding of the interdependencies of functional groups
- Track record of advancing novel therapeutic agents from preclinical to clinical development as Project or CMC leader
- Demonstrated experience managing CROs and CMOs to provide high-quality, timely and on-budget studies and product
- Thorough understanding of cGMPs as well as FDA, EMA, USP/PhEur and ICH guidelines
- Experience in authoring CMC sections of regulatory filings IND/IMPD and NDA/MAA
- Outstanding written and verbal communication skills demonstrating the ability to clearly articulate CMC strategies to a diverse audience
- Desire and ability to work in a fast paced, cross-functional, flexible and team-oriented environment.
JOB CODE: SMCMC
Constellation Pharmaceuticals is an Equal Opportunity Employer, a participant in E-Verify and offers a comprehensive benefits package, including health, dental, 401(k), paid vacation, tuition reimbursement, and much more.
We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time.