Director of CMC

  • Location
    San Diego, California
  • Job type
    Direct Hire
  • Salary
    $180,000.00/Hour
  • Category
    Industrial & Manufacturing - VP - Manufacturing

Our client is a global immuno-oncology biopharmaceutical company and is seeking a Director of CMC. In this role, you will report to the VP of CMC and will be responsible for leading the process development, manufacture, release and stability of portfolio drug candidates with a particular focus on drug substance and analytical activities. You would also assist in the technical transfer, process and method development, optimization, qualification and validation of activities related to all manufacturing operations, as well as manage drug candidate supply chain by efficient manufacturing planning, maintenance of inventory and distribution of clinical trial material in support of studies in all territories.

This is a full time permanent role on-site in San Diego, CA. Please apply today for more information!

Qualifications:

Minimum BS degree in a scientific/engineering discipline, M.S. degree or Ph.D. Degree in Pharmaceutics, Chemistry, Chemical Engineering, or related field is preferred
10-15 years of experience in the pharmaceutical/biotech industry
8+ years of experience in pharmaceutical development of small molecules drug candidates
5+ years’ experience in small molecule drug substance process development/manufacture and analytical methodology development/validation
5+ years of experience in formulation/process development of poorly soluble drug candidates
Authored CMC sections of regulatory filings for US, Europe, and Japan

Responsibilities:

Lead the process development, manufacture, release and stability of portfolio drug candidates with a particular focus on drug substance and analytical activities
Assist in the technical transfer, process and method development, optimization, qualification and validation of activities related to all manufacturing operations
Manage drug candidate supply chain by efficient manufacturing planning, maintenance of inventory and distribution of clinical trial material in support of studies in all territories.
Evaluate third-party manufacturers working with Quality Assurance and Regulatory Affairs, assist in negotiating effective supply/technical agreements. Identify and manage contract analytical laboratory site(s) required to guide and support third party manufacturing relationships
Design and oversee execution of necessary DOE and process development activities in preparation for Registration and Validation activities.
Assist in the management and execution of Primary/Registration activities in preparation for regulatory filings
Author relevant sections of regulatory documents, including Investigator’s Brochure, Pharmacy Manual, Study Protocols, IND filings, IMPD, and DMFs
Review and approve master and executed batch records from all manufacturing activities; analytical release testing, stability studies and investigations.
Participate in product development project teams as CMC functional area representative


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Reference number US_EN_2_108175_328498