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Associate Director, Analytical Development/Quality Control (CMC)

Frontier Medicines
South San Francisco, CA
  • Expired: June 10, 2022. Applications are no longer accepted.

Frontier Medicines is seeking a highly motivated Associate Director, CMC Analytical Development/Quality Control to provide the direction and oversight of technical activities associated with analytical methods development, qualification, and validation in support of development of Frontier’s small molecule drug candidates from early to late-stage development. You will oversee all aspects of the analytical activities supporting manufacturing of the drug substance (DS) and drug product (DP), release and stability testing of the DS and DP, and manage internal and external analytical lab operations. The successful candidate must possess proven leadership experience with a track record of advancing small molecules through various stages of clinical development. A solid understanding of the industry’s complex regulatory requirements and a commitment to ensuring quality, is essential.

This position is located in our South San Francisco office. Requirements What will you be doing? Provide technical expertise for analytical methods for drug substances (DS) and drug products (DP). Experience in early through late-stage development projects is preferred. Utilize working knowledge of analytical techniques, such as HPLC, UV-Vis, GC, LC-MS, IR, NMR, thermal techniques, XRPD, PSD, and dissolution. Develop specifications and revise methods for global drug substances and products. Identify external contract labs, manage analytical related activities, and manage contracts at the contract labs or at the CMO for DS and DP. Work with Process Chemistry, Drug Product Formulation and Development, Quality Control, Quality Assurance, Clinical Supply Chain, and Analytical Scientists to implement and transfer phase-appropriate analytical methods with CMO’s. Author and review technical documentation for regulatory filings such as INDs/NDAs, IMPDs/MAAs. Work with clinical supply chain on activities associated with testing clinical trial materials (CTMs). Manage stability programs for drug substances and drug products. Manage junior scientists and provide scientific guidance, as needed. Manage internal analytical laboratory operations, as needed. Traits we believe make a strong candidate: PhD.

in analytical chemistry or related science with 5+ years, MSc. with 8+ years, or BS with 10+ years of experience in Analytical Development/Quality Control of small molecule drug substances and drug products Excellent scientific knowledge of modern analytical methodologies and working knowledge of organic chemistry. Strong technical problem-solving and troubleshooting abilities. Effective verbal and written communication skills. Ability and track record of successfully working in cross-functional teams to advance projects through various stages of clinical development. A proven track record of implementing phase appropriate quality control strategies. Direct experience in managing analytical development/QC activities at CROs and CDMOs. Direct experience in technology transfer of validated analytical methods between CROs and CDMOs. Experience in authoring analytical related sections of INDs and NDAs. Working knowledge of cGMP regulations and ICH guidelines as well as pharmacopeia standards. Benefits Health Care Plan (Medical, Dental & Vision) Retirement Plan (401k, IRA) Life Insurance (Basic, Voluntary & AD&D) Paid Time Off (Vacation, Sick & Public Holidays) Family Leave (Maternity, Paternity) Short Term & Long Term Disability Training & Development Free Food & Snacks Wellness Resources Stock Option Plan

Frontier Medicines

Address

South San Francisco, CA
USA

Industry

Manufacturing

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