Head of Analytical Chemistry

Associate Director / Director of Analytical Chemistry

The ideal candidate will lead Cyteir's effort in developing and validating robust analytical methods 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 all analytical activities related to the drug substance and drug product. Being a key member of the CMC team, the Associate Director / Director of Analytical Chemistry will have a deep expertise of Analytical Equipment, and regulatory guidances. The Analytical Lead will be collaborating frequently with the drug substance, drug product and on occasion with the Discovery Chemistry, DMPK, and Toxicology teams.

Job Responsibilities:

· Responsible for all activities related to developing, validating, and verifying analytical methods for small molecules

· Oversight of analytical method development activities to support drug substance and drug product development, scale up, and manufacturing under GLP and GMP at CDMOs

· Develop analytical methods are that rugged, compliant and QC friendly

· Apply industry best practices to address complex issues involving solid state characterization, impurity/degradant control, cleaning validation, microbial testing, forced degradation and compendial methods

· Apply fundamental analytical chemistry principles to solve method development and transfer challenges

· In collaboration with the Head of CMC, define timelines and budget to support all analytical activities

· Work collaboratively with Quality Assurance and Regulatory to author/review analytical documents, stability results, and regulatory documents pertaining to drug substance as well as drug product and approve as required

· Write sections of regulatory IND/IMPD and NDA/MAA documents pertaining to Analytical

· 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

Job Qualifications:

· Ph.D. (or MS) and 12+ combined years of postdoctoral research experience and/or experience in developing and validating analytical methods for small molecules in biotech and/or pharma industry

· Experience with analytical method development and validation, tech transfer, drug substance and drug product characterization, and working with CDMOs

· Demonstrated successful experience guiding the analytical relevant CMC sections/quality modules for regulatory submissions and experience with responding to regulatory authority queries.

· Experience with both early and late-stage analytical development of oral solid dosage forms, application of QbD and statistical design of experiments (DOE) 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 analytical CMC support of early and 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