Description
Kezar Life Sciences (NASDAQ: KZR), a clinical - stage biotechnology sciences company located in South San Francisco, is seeking a Sr. Director of Pharmaceutical Development. This position will report to the VP of Pharmaceutical Development & CMC and be responsible for all facets of drug product design, Contract Development and Manufacturing Organizations (CDMOs) selection, and CDMO oversight for development activities and CTM manufacturing.
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:
Plan and oversee all sterile parenteral and solid - oral dose formulation development activities from preclinical development, through Phase 3. Introduce registration and marketing authorization applications. Ensure all activities for drug products are aligned with company project goals and timelines.
Work collaboratively with internal stakeholder functions such as Project Management, Clinical, Quality Assurance, Regulatory Affairs, and Finance to meet program goals. Represent CMC on development teams. Coordinate seamlessly with CMC colleagues overseeing drug substance, analytical development, and clinical supply management
Manage all development - related activities related to drug products internally and with external vendors. Select and manage CDMOs for process technology transfer, manufacturing development, and drug product manufacturing
Implement Quality by Design (QbD) and apply risk - based principles to drug product development programs, including technical & quality risk assessments, design of experiments, and identification of critical material and quality attributes, critical process parameters, and manufacturing control strategies
Review drug product - related technical documents, including formulation and process research & development reports, masterbatch record documentation, campaign reports, and validation protocols & reports. Oversee reviews of executed batch record documentation and provide technical input toward batch release. Drive resolution of CDMO deviation & event investigations
Prepare internal pharmaceutical development reports and other technical documentation required for regulatory submissions including composition, review, and approval of the requisite IND, CTA, IMPD, NDA, MAA, or other filings. Assist in responses to health authority questions
Ensure all work is conducted in accordance with applicable policies and procedures, CGMP, and regulatory standards & guidelines. Maintain an understanding of global laws & regulations applicable to the pharmaceutical industry
Manage direct reports and oversee internal laboratory R&D activities, including clinical formulation development & prototyping
Coordinate with clinical supply management and clinical operations to ensure accurate forecasting and timely supply of clinical inventory, assist in the development of commercial forecasting
Lead and participate in initiatives to improve functional processes and technical operations within Pharmaceutical Development & CMC
Assist senior management and participate in due diligence for potential business development efforts with external parties
REQUIREMENTS:
Ph.D. in pharmaceutical sciences, chemical engineering, chemistry, related discipline, or equivalent qualifications and experience
Minimum of 10 years of pharmaceutical development & CMC experience
Significant or majority experience with all aspects of phase - appropriate development and manufacturing of sterile liquid and lyophilized parenteral formulations for small - molecule NCEs for preclinical through Phase 3 studies and into registration / marketing authorization applications
Experience with self - injection drug - device combination products is a plus
Demonstrated success driving drug product development and CMC activities and timelines in a virtual pharma business setting through management of external partners and CRO / CDMOs
Excellent leadership, oral and written communication, and interpersonal skills
Track record of successfully driving and managing drug product development programs, overcoming challenges, and managing risks. Must be able to prioritize and meet deadlines in a fast - paced environment, adaptable to setbacks with exceptional problem - solving skills. Understands and anticipates the impact of business and commercial needs on advanced - stage drug development
Distinguishes research from development
Capable of managing budgets, preparing RFPs, reviewing, and approving work orders, and liaising with legal and quality departments for MSA and QTA agreements
Excellent working knowledge of CGMP, regulatory guidance, and compendial requirements, including FDA, EMA, ICH, WHO, USP-NF, and EP
Excellent technical writing, data presentation & analysis skills, including the creation of publication - quality tables & graphs
Demonstrable experience as a primary author of CMC sections in regulatory filings, such as IND, IMPD, and NDA / MAA
Fastidiously detail - oriented and organized
Strong project management skills
Impeccable attention to controlled document filing / archiving and data QC
Fluent in the Microsoft ecosystem, including Office & SharePoint, and PDF publication & editing software such as Adobe Acrobat
Comfortable with electronic records & digital workflows
Up to 15 % of foreign and domestic travel
Kezar Life Sciences is an Equal Opportunity Employer
