Director/ Sr. Director, Cmc

A well funded Third Rock start up located in South San Francisco is seeking a Director/ Sr. Director, CMC. Reporting to the SVP, Chemistry, the incumbent will be required to work flexibly across a number of small molecule drug development programs with responsibilities for both drug substance synthesis & scale-up and drug product development and manufacturing campaigns. All activities are expected to be outsourced.

RESPONSIBILITIES:

As the technical and scientific expert,

• Lead and manage formulation development, which may entail one or more of
• CGMP API manufacturing campaigns
• Oversee analytical method development, review results, QC and approval
• Scale-ups and technology transfer
• Lead and manage multiple and concurrent drug substance projects, with responsibilities including:
• Immediate and sustained release products (e.g. once-daily, once-monthly etc)
• Identify CMC-related risks and facilitate mitigation planning
• API process development, route scouting and optimization and validation
• Visit vendors to oversee manufacturing campaigns and participate in audits
• Oversee manufacture of cGMP drug product manufacture, labeling & packaging, including review and approval of batch records
• Set up CMC team meetings, cross-functional team meetings to ensure timely delivery of clinical supplies and documentation
• Serve as functional group representative on project teams and regularly report to Senior Leadership
• Fixed dose combination
• Work with QA to ensure compliance in all of the outsourced activities
• Oral and injectable product development (e.g. tablets, capsules, IV and IM etc.)
• Pro-drug design and evaluation
• Contribute to the drafting of the CMC sections of regulatory submissions (e.g., INDs, CTAs, NDAs) and respond to any queries from regulatory authorities
• Salt form selection
• Evaluate, recommend and select vendors for drug substance manufacture, formulation development and drug product manufacture

QUALIFICATIONS:

• 10+ years experience in the pharmaceutical industry, directly related to above mentioned CMC activities, with sufficient exposure to both DS and DP manufacturing and troubleshooting.
• PhD in organic chemistry, pharmaceutics, chemical engineering or related field
• Excellent attention to detail and commitment to providing accurate, high-quality work.
• Strong interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team.
• Good organizational skills and the ability to manage multiple competing priorities.
• Experience working, collaborating with, and managing CDMOs.
• Good knowledge of formulation options and troubleshooting
• Excellent written and oral communication skills, including experience in technical writing in support of regulatory submissions.
• Good knowledge and understanding of cGMP of small molecule DS/DP and of the US, Canadian and EU regulatory environments; previous experience with IND and CTA CMC submissions preferred.