Director / Sr. Director, Drug Substance Manufacturing

Kezar Life Sciences (NASDAQ: KZR), a clinical-stage biotechnology sciences company located in South San Francisco, is seeking a Director / Sr. Director, Drug Substance Manufacturing. This position will report to the President and Chief Scientific Officer. The ideal candidate will be responsible for all facets of drug substance manufacturing of small molecule clinical candidates to support a growing biotechnology company.

Kezar is focused on small molecule drug discovery and development to target immune-mediated diseases and cancer. Kezar’s lead product candidate, KZR-616, a selective inhibitor of the immunoproteasome, is being evaluated in Phase 2 clinical trials for the treatment of severe autoimmune diseases. KZR-261, Kezar’s first oncology candidate targeting the protein secretion pathway via the Sec61 translocon, is now being studied in a Phase 1 clinical trial in several oncology indications.

Responsibilities

• Develop, plan, and oversee drug substance (DS) related activities from preclinical development through Phase 3 studies
  
• Manage Contract Development and Manufacturing Organizations (CDMOs) for process technology transfer and optimization, non GMP and cGMP manufacture, and supply of Drug Substance (DS) in support of ongoing clinical programs
• Execute plans in accordance with cGMP, ICH, EMA, and FDA regulations
• Partner with key stakeholders including Discovery, Quality Assurance, Regulatory Affairs, Finance, and Program Management
• Author and review relevant sections for regulatory submissions
• Prepare, review, or edit cGMP batch records, CMC regulatory, IP filings, and quality documents

Requirements

• PhD/MS in chemistry is required
• Minimum of 10 years of pharmaceutical development experience (Director level) or 15 years (Senior Director level)
• Experience with all aspects of DS activities for small molecules for preclinical through Phase 3 projects including: process development, management of CDMOs, contracts, technology transfer, regulatory and quality requirements, analytical development, and authoring regulatory dossiers (IND and IMPD filings)
• Experience with process validation and NDA filings is desired
• Track record of successfully driving and managing programs, overcoming challenges, and managing risks
• Experience with the scale-up of complex small molecules
• Strong organizational and project management skills
• Excellent communication and interpersonal skills in working across the organization

Kezar Life Sciences is an Equal Opportunity Employer