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Kezar is seeking a Chemistry, Manufacturing, and Controls (CMC) Project Manager to manage and drive the execution of all the CMC activities for Kezars 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 Kezars 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.

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 development in support of clinical development projects and advancement of assets through the pipeline.
• Expertise with PM tools (e.g.: MS project, Smartsheet, etc.) and other software applications.
• Strong written and oral communication skills with attention to detail.
• Ability to see the big picture while also able to roll up ones sleeves and get in the weeds of projects.
• Ability to think outside of the box and challenge the status quo.
• Desire to work in a fast-paced, innovative environment.
• Natural collaborator who enjoys working in a cross-functional team. Demonstrated leadership and interpersonal skills that have enabled you to successfully align project teams.
• The project management style should be one that is recognized as being collaborative and flexible and being able to manage effectively across the varied backgrounds and styles in the cross-functional teams
• Solid organizational, time management, and collaborative skills with the ability to effectively manage ad hoc requests.
• Project Management Professional (PMP) certification desirable.

Compensation and Benefits

The salary range for this position as Director, CMC Project Management at our South San Francisco, CA corporate office is $225,000 - $235,000. 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.