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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 Kezars 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 Kezars 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 Bachelors 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: Join Our Team - Kezar Life Sciences Inc.
About Kezar Life Sciences
We are developing first-in-class, small molecule therapies designed to inhibit multiple disease-driving cellular pathways by targeting key intracellular proteins. Since inception, our mission has been to deliver unique treatments that can better the lives of patients fighting difficult-to-treat chronic diseases. Our team is passionate about discovering promising targets that were previously unidentified or undruggable and have the potential to change the treatment paradigm for a range of conditions.
Here at Kezar, our employees are our greatest asset and are the drivers of the Companys success. Every day, our team of passionate professionals are converting scientific ideas to first-in-class assets that have the potential for significant clinical impact in the most difficult-to-treat diseases. Together, we are focused on the common mission of helping patients overcome their chronic conditions and live a better life.
We believe in fostering a culture of trust and respect for all team members at all levels. Our employees are encouraged to question, exchange views and discover new ways to address issues and solve problems. We welcome differences in ideas, styles and practices to accomplish our goals. Hard working, innovative and compassionate are qualities every Kezar employee should possess and were always looking for equally dynamic and motivated individuals to join our team.
Information for Recruitment Agencies
Kezar Life Sciences does not accept from recruiters/agencies any unsolicited resumes, or any candidate information including blinded resumes and will not be responsible for any fees related to resumes or candidate information that is unsolicited. Please do not contact hiring managers or Kezar Life Sciences employees directly with any information related to a resume or a candidate. We handle all recruiting through our internal Human Resources team, and we will reach out to you directly should we wish to engage in a search. Your willingness to comply with this will significantly impact any decision we may make about doing business with you.
Kezar Life Sciences
