Head of Process Chemistry
Cyteir therapeutics seeks and exceptional candidate who shares our passion and drive to make a difference in the lives of patients. The ideal candidate will lead Cyteir’s effort in developing robust, scalable manufacturing processes for Cyteir’s portfolio of small molecule development candidates. The position reports to the Head of CMC and has functional responsibilities and oversight of our CDMOs for process chemistry, scale-up, and drug substance manufacturing. Being a key member of the CMC team, the Associate Director / Director of Process Chemistry will have a deep expertise in process chemistry and will be collaborating frequently with the drug product team, analytical chemistry team and on occasion with the Discovery Chemistry, DMPK, and Toxicology teams.
- Responsible for all activities related to small molecule drug substance development and manufacturing
- Oversight of drug substance process chemistry development, scale up, and manufacturing for GLP studies and GMP manufacturing at CDMOs
- Develop manufacturing processes that are scalable, safe, cost-effective, and environmentally friendly
- Apply industry best practices to address complex issues involving salt, polymorph and particle size attributes, synthesis, reaction kinetics, process safety, impurity profile management, processibility, and equipment design
- Partner with Discovery Chemistry on synthesis to facilitate candidate nomination
- Apply fundamental chemistry and engineering principles to solve synthesis, process design, production equipment, and scale-up challenges
- In collaboration with the Head of CMC, define timelines, production scale, and budget to support all development candidates
- Work collaboratively with Quality Assurance and Regulatory to review analytical documents, stability results, manufacturing batch records and regulatory documents pertaining to drug substance and approve as required
- Write sections of regulatory documents pertaining to drug substance
- Interact with cross functional teams to provide CMC technical information, guidance, and support
- Act in accordance with all Cyteir Therapeutics policies and be a positive contributor to company culture
- Ph.D. (or MS) and 10+ combined years of postdoctoral research experience and/or experience in small molecule drug development and manufacturing in biotech and/or pharma industry
- Experience with process chemistry development, scale-up, tech transfer, drug substance characterization and working with CDMOs
- Experience in cGMP manufacturing, leveraging, and managing US and International CRO/CDMOs for the manufacture of regulatory starting materials and drug substances.
- Experience guiding the CMC sections/quality modules for regulatory submissions and knowledge of current regulations.
- Experience with quality by design, process validations and statistical design of experiments (DOE) is a plus
- Experience with both early and late-stage process development is a plus
- Strong interpersonal skills are required, and the successful candidate will work in a cross-functional matrix environment and will be expected to influence the direction of the late-stage clinical programs
- Excellent written and verbal communication skills
- A thorough understanding of ICH guidelines, GMPs, and relevant regulatory requirements
- A sense of adventure and excitement to help build a successful biotech company and work in a highly dynamic research environment
- Ability to travel domestically and/or internationally to accomplish objectives, when necessary