Director/Senior Director, CMC

Director/Senior Director, CMC

The ideal candidate will provide experienced leadership in overseeing and coordinating all CMC-related activities, including process, analytical, and formulation development and manufacturing, across the preclinical and clinical pipeline. This individual will have deep expertise and experience in process chemistry and manufacturing of small molecules and will interact and collaborate cross-functionally with scientists throughout the organization.

Job Responsibilities:

  • Oversee process development, analytical development, and manufacturing of drug substances
  • Coordinate formulation development, analytical development and manufacturing of drug products, including packaging and labeling
  • Develop process and control strategies for the drug development programs
  • Identify, evaluate, and manage external CDMO and CRO activities
  • Ensure delivery of robust, scalable and cost-effective manufacturing processes for drug substances and drug products
  • Develop analytical support for both drug substance and drug product: phase appropriate method development, method verification/transfer, and validation
  • Work collaboratively with Quality Assurance and Regulatory to review analytical documents, stability results, manufacturing batch records and regulatory documents and approve as required
  • Responsible for writing CMC sections of regulatory documents (IND, IMPD) and represent the company for regulatory agencies CMC-related queries
  • Interact with cross functional team 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 small molecule drug development and manufacturing in biotech and/or pharma industry
  • Experience with process and formulation development, including the establishment of analytical methods to support both drug substance and drug product characterization and release
  • Experience with late-stage clinical development
  • Experience in cGMP manufacturing, leveraging and managing US and International CRO/CDMOs for the manufacture of regulatory starting materials, cGMP drug substances and drug products
  • Experience guiding the CMC sections/quality modules for regulatory submissions and knowledge of current regulations. An ability to identify and resolve critical issues
  • 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 with an ability to convey CMC strategy and results to a varied audience
  • A thorough understanding of ICH, GMP, 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
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Director/Senior Director, CMC

APPLY NOW