Sr. Director, Process Validation

Join our Mission to Protect Humankind Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. WHAT we do is every bit as important as HOW we do it Our work together is guided by four enduring core values: RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered. AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives. MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making. Summary: The Sr. Director, Process Validation has the accountability for commercial process validation of the Vaxcyte commercial processes. In this role the Sr. Director, Process Validation will be a part of the Global MSAT leadership team reporting to the VP of Global MSAT. This role will be immersed in all aspects of operations in a commercial setting, which includes development, support, and execution of commercial process validation. The role will be responsible for ensuring that process validation activities are performed in a consistent and controlled manner to support manufacture of drug substance (DS) and drug product (DP). In addition, the role will be responsible for early engagement in tech transfer from process development and BLA-enabling validation strategy. This role will support the development of Process Validation/Process Performance Qualification/Process Verification/CPV strategy for the life cycle of products, ensuring alignment with regulatory guidelines and industry standards. This role will also apply a fundamental understanding of bioprocessing to support continuous process validation for commercial processes, new site/plant start-up, execution of validation projects and/or protocols and the collection of data to support completion of process validation activities. The position will provide guidance for the generation, resolution and closure of deviations and ensure safety and compliance of validation activities including support for regulatory filing, inspection, and other CMC and technology team activities. This position is also expected to have a strong influence on engineering, facility, systems and method validations within the commercial organization. Manufacturing Science and Technology (MSAT) is responsible for successfully and seamlessly transitioning the vaccine process from Process Development to Commercial, developing and executing technical launch and commercialization strategy, continuously improving process robustness through to end of lifecycle, commercial process validation, and ensuring best possible patient outcomes while creating value for the enterprise. As part of the Commercial Manufacturing and Supply Chain organization, MSAT will lead the technical and process support for end-to-end commercial manufacturing, including Polysaccharides, Carrier Proteins, Conjugation across all DS production and formulation, fill finish and packaging across all DP production. Essential Functions: DS/DP Validation – Provide strategic and scientific leadership for process verification and validation with internal and external stakeholders and ensure successful execution of launch plans and post launch commercial activities. Organization – Provide process validation representation for manufacturing processes. Support resourcing recommendations on staffing requirements to meet organizational goals. Interface - Collaboration with cross-functional teams across the network, including Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering, to drive the successful commercialization of pipeline products. Support technical services - Support of our internal and external manufacturing network validations, including qualification of raw materials. Process validation and comparability - Provide support for the execution of process validation and process comparability activities. Regulatory - Engage In technical reviewing and authoring of regulatory filings and responding to questions received from health authorities. Effectively communicate the scientific and commercial rationale for validation to the Boards of Health for regulatory submissions for commercialization. Communicate - Effectively and efficiently communicate process validation performance to key stakeholders (internal-facing and external-facing). Connect and build strong working relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively. Executing for Results - Set clear and challenging goals and take accountability for driving results. Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and move forward through complex situations. Leadership – Provide technical leadership for validation and contribute as a member of the Global MSAT organization, with an aim to ensure effective and efficient delivery of our life enhancing therapies to our patients. Travel - 10-30% domestic and international travel required. Requirements: Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, Biotechnology or related discipline with a minimum of 10 years of relevant experience for Ph.D., 12 years for M.S./M.A. or 14 years for B.S./B.A. Complex conjugate vaccine process validation experience preferred with a background of MSAT or Technical Operations or Late phase process development. Broad experience in understanding aspects of process characterization, product development, multivalent vaccines, and relevant fill finish unit operations across multiple operational scales. Technical leadership experience in Process or Product validation strategy supporting technology transfer, project management and regulatory documentation. Excellent organization, problem solving and strategic planning skills. Highly skilled in both verbal and written communication with the ability to interact effectively with people of diverse backgrounds and perspectives. Proactively recognizes needs and potential challenges and collaborates to implement effective solutions. The ability to seek and analyze data from a variety of sources to support decisions and to align others with the organization's overall strategy. An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry. Reports to: Vice President, MSAT Location: San Carlos, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component. Salary Range: $252,000 – $271,000 (SF Bay Area). Salary ranges for non-California locations may vary. Vaxcyte, Inc. 825 Industrial Road, Suite 300 San Carlos, CA 94070 We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. LI-JN1