Director/Sr. Director of CMC

We are seeking a motivated and versatile individual to lead our CMC group as Director/Sr. Director of CMC. The successful candidate will be responsible for managing our internal team of scientists and external CROs/CMOs in developing robust chemical processes to enable the successful manufacture of drug substance for pre- and post-IND activities. This position will be responsible for the design of new syntheses and process improvements, oversight of non-GMP and GMP manufacturing, and assisting in the writing of regulatory documents and will work closely with other CMC functional areas, the Quality unit, and outside contractors. The candidate should have hands-on experience in drug development, a proven track record of solving complex synthetic problems, and the ability to work effectively in a team environment. Some domestic and international travel is required.

Key Responsibilities:

  • Provide synthetic expertise and oversight of chemical process development, including hands-on chemistry in the lab
  • Manage a mixture of internal and external activities to ensure delivery of drug substance to meet project timelines
  • Work with project team to identify drug substance requirements and purity standards
  • Generate data for regulatory filings and author relevant sections in regulatory documents
  • Author of technical documents

Qualifications:

  • PhD in Chemistry with a minimum of 8 years of experience in process chemistry within the biotech or pharmaceutical industries
  • Strong technical skills in organic chemistry and multi-step chemical synthesis
  • Experience in managing CROs/CMOs and GMP manufacturing
  • Strong problem solving and troubleshooting skills
  • Strong written and oral skills
  • Experience in writing regulatory documents and in regulatory submissions

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