Associate Director, CMC Project Management

Kezar Life Sciences is seeking an Associate Director, CMC Project Management to help plan, manage, and drive the execution of CMC development and manufacturing activities for all Kezar’s clinical assets. Reporting to the Senior Vice President, Development Operations, this Associate Director will partner closely with Pharmaceutical Development, and Manufacturing, and will develop and implement CMC project plans and ensure alignment of deliverables with the clinical development plan. The expectation is to be onsite at our South San Franciso, CA office at least three days per week.

Kezar Life Sciences is seeking an Associate Director, CMC Project Management to help plan, manage, and drive the execution of CMC development and manufacturing activities for all Kezar’s clinical assets. Reporting to the Senior Vice President, Development Operations, this Associate Director will partner closely with Pharmaceutical Development, and Manufacturing, and will develop and implement CMC project plans and ensure alignment of deliverables with the clinical development plan. The expectation is to be onsite at our South San Franciso, CA office at least three days per week.

Key responsibilities include:

• Partners with the CMC/Pharmaceutical Development team to plan and prioritize CMC activities across the clinical portfolio.
• Works with process chemistry, formulation development, analytical development and clinical drug supply to develop and maintain integrated CMC project plans and timelines for all clinical assets. Ensures that plans incorporate cross-functional input from regulatory CMC, quality, toxicology and clinical operations and clinical development
• Leads CMC cross-functional and department team meetings to develop strategy and monitor progress. Develops agendas and produces high quality meeting minutes and related outputs to monitor program status.
• Ensures timely communication of changes in program strategy, issues and risks to team members and other functional areas as appropriate.
• Facilitates team discussion and agreement on clear, concise program goals. Oversees deliverables to support program objectives; identifies risks and supports the development of risk mitigation plans.
• Provides project management support for functional areas. Organizes subteam meetings and ad-hoc working groups as needed to address specific topics.
• Works with functional leads and finance to develop budgets for CMC activities.
• May interface with vendors to keep manufacturing activities on track.
• Provides input for regular project status updates to senior leadership.
• Leads or contributes to department and company initiatives for continuous improvement.

Preferred Qualifications include:

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.

• Typical experience for an Associate Director includes a Bachelor’s degree with 10+ years of relevant experience. Candidates with direct experience in the biotech industry as a CMC functional area scientist and/or project manager, including management of cross-functional CMC or R&D project teams for multiple projects will be considered in lieu of actual years of experience. Candidates with therapeutic experience in oncology or immunology, as well as those with an advanced degree and/or Project management certification (PMP or equivalent) will be considered uniquely qualified for this role.
• Demonstrated understanding of the drug development process from a CMC perspective – drug substance development, formulation development, analytical, quality, regulatory.
• Self-motivated, comfortable in fast-paced small company environment with minimal direction. Able to orchestrate multiple projects simultaneously and adjust workload based upon changing priorities.
• Effective communication, interpersonal, collaboration, and negotiation skills. Demonstrated ability to drive results without formal authority.

Compensation and Benefits

The salary range for this position as Associate Director, CMC Project Management at our South San Francisco, CA corporate office is $195,000 - $205,000. Factors such as academic credentials and relevant experience will influence the actual salary offered. In addition to a competitive market-based salary, Kezar Life Sciences offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package including 401K. Additional information about our total rewards program can be found here: