Director, CMC Project Management

Kezar is seeking a Chemistry, Manufacturing, and Controls (CMC) Project Manager to manage and drive the execution of all the CMC activities for Kezar’s development programs. Reporting to the VP of Pharmaceutical Development, the Director of CMC Project Management will develop and oversee internal CMC department project plans and timelines. This person will ensure alignment of CMC department objectives with other functional disciplines and partner with the project team lead to support all phases of asset development from preclinical to commercialization.

The ideal candidate will thrive in a fast paced, goal-oriented environment and enjoy working with team members across Kezar’s rapidly growing company. The expectation is that the Director of CMC Project Management will be onsite at our South San Francisco, CA office at least three days per week.

Kezar is focused on small-molecule drug discovery and development to target immune-mediated diseases and cancer. Kezar’s lead product candidate, zetomipzomib, is being evaluated in clinical trials for the treatment of lupus nephritis and autoimmune hepatitis. Kezar is also conducting an oncology clinical trial of KZR-261, the first candidate from its novel platform targeting the protein secretion pathway. This research platform has the potential to generate additional small molecule compounds with therapeutic potential in cancer and inflammation

Key Responsibilities include:

• Responsible for the development and implementation of the integrated project plans within the Pharmaceutical Development department, including oversight of tasks relating to technical CMC and clinical supply chain objectives required for regulatory filings and drug product approvals in support of all phases of clinical development, manufacturing scale-up, and commercialization.
• As a key member of the CMC/Pharmaceutical Development team, plan and prioritize CMC activities across the clinical portfolio and in accordance with the Corporate and Functional goals.
• Develop close working relationships with colleagues in process chemistry, formulation development, analytical development, and clinical drug supply to design and maintain integrated CMC project plans and timelines for all clinical assets. Ensure that plans incorporate cross-functional input from regulatory CMC, quality, toxicology, clinical operations, and clinical development.
• Develop and maintain relationships across the cross-functional teams. Facilitate discussions, gain alignment towards goals, and set priorities towards expediting the development and commercialization of Kezar development programs.
• With the departmental leadership, develop and maintain effective professional relationships with the selected contract development and manufacturing organizations (CDMO) supporting the contracted product development activities.
• Work with functional lead and finance to develop budgets for CMC activities according to corporate and departmental goals. Manage approved operational budgets and provide quarterly reports as required.
• Facilitate decision making, capture and document key decisions and escalate issues appropriately to effectively resolve them in a timely manner.
• Develop and maintain risk assessments associated with Pharmaceutical Development, CMC, and Supply Chain Monitor and track these risks within the asset development team and develop and recommend to the Pharmaceutical Development leadership such mitigation strategies.
• Create and maintain CMC dashboards supporting corporate goals and provide status updates for regular portfolio meetings and to senior leadership.

Not sure if you are qualified for this position? We know that skills and experience can show up in different ways and we welcome resumes from a broad range of applicants. You are encouraged to apply even if you do not meet each of the listed preferred qualifications.

Preferred Qualifications Include:

• PhD or MS in Pharmaceutical Sciences, Chemical Engineering, or related discipline with 5+ relevant experience. Candidates without an advanced degree but who have significant years of demonstrable CMC project management experience in the biopharmaceutical field are also encouraged to apply.
• Excellent understanding of the drug product development process from pre-clinical through commercialization and Life Cycle Management including drug substance development, formulation development, analytical, quality, regulatory and clinical development.

• Demonstrated ability to manage cross-functional teams and diverse sets of stakeholders.
• Multitasking ability to oversee multiple projects and reach milestones on time.
• Strong project management skills with a proven track record of successful pharmaceutical develop