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 Director for Global ASAT Drug Substance (DS) will lead and facilitate the analytical (development, tech transfer and lifecycle of commercial manufacturing) program prioritization, and execution to drive the successful launch of products. This role provides leadership in the development and implementation of analytical methods to characterize and ensure the quality of drug substances throughout the lifecycle of commercial manufacturing, with a focus on understanding and controlling critical quality attributes (CQAs) of the drug substance, adhering to all relevant regulatory standards and guidelines. In this role the incumbent will serve as the analytical lead and SME supporting the analytical launch readiness and testing support for commercial supply of glycoconjugate drug substances, including the testing of activated polysaccharide, conjugated material, and associated drug substances. Works in alignment with network organization to ensure on-time execution and appropriate planning for commercial lifecycle management and coordinating cross-functional efforts for regulatory filings, facility readiness, and launch supplies. This role also provides leadership to ensure that the organization is equipped to effectively communicate the analytical and scientific rationale for Raw materials, DSI and DS testing to internal stakeholders, relevant CMOs, and to regulatory agencies. The incumbent will work with the organization to ensure on-time execution and appropriate planning for the analytical readiness and lifecycle management for commercial manufacturing. Reporting into the Senior Director for Global ASAT. The Director will collaborate on overall program strategy, with primary responsibility and accountability for the analytical leadership for commercial drug substance (DSI and DS) functions across the network. The Global MSAT (including ASAT) group is responsible for successfully and seamlessly transitioning the vaccine processes and analytical methods from Process Development to Commercial, developing and executing technical launch and commercialization strategy, continuously improving process robustness through to end of lifecycle, 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 aspects of analytical and process support for end-to-end commercial manufacturing, including Polysaccharides, Carrier Proteins, Conjugation across all Drug Substances (DS) and Drug Products (DP). Essential Functions:
- DS Commercialization - Provide technical and scientific advice for internal and external stakeholders in support of the successful execution of launch plans and post-launch commercial activities. Manage and support the analytical control strategy with advanced state-of-the-art analytical equipment and technologies and routine trouble shooting. Life Cycle Management of process and product.
- Analytical validation and comparability - Develop and validate new analytical techniques and methods. Provide leadership for analytical validation and comparability activities. Effectively communicate the scientific and commercial rationale of analytical aspects to the Manufacturing organization for commercialization.
- Analytical Characterization - Provide analytical support activities related to method development and qualification/validation, product characterization, and comparability assessment for multiple programs
- Tech Transfer - Provide technical support for complex analytical challenges. Tech-transfer new technologies - support technical transfers and integration of new technologies. Lead Tech Transfer Support (including comparability protocols and reports).
- Support Technical Teams - Support of our internal and external manufacturing network, including materials management and data analytics. Review/Author method validation protocols, reports, and transfer activities. Review test data for release, stability, and characterization plans for projects. Review analytical documents including but not limited to protocols, reports, and procedures. Support domestic and international packaging and shipments.
- 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 analytical to the Boards of Health for regulatory submissions for commercialization. Contribute to CMC analytical aspects of regulatory filings; review and assemble information for analytical sections in regulatory submission documents (e.g. IND, IMPD, NDA). Support World-Wide Post Approval Submissions.
- Analytical thought partner - Serve as a thought partner with Regulatory, CMC, Quality, Supply Chain, Sourcing, and Process Engineering colleagues.
- Interface - Collaboration with cross-functional teams across the internal and external network to drive the successful development and commercial launch of pipeline products. Work in a team environment to manage third-party vendors including analytical method implementation, qualification/validation, and transfer for drug substance and drug product projects.
- Communicate - Effectively and efficiently communicate process 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.
- Leadership - Contribute as Global ASAT lead and as member of the Global Manufacturing Operations, with an aim to ensure effective and efficient delivery of our life-enhancing therapies to our patients. Act as the CMC team analytical lead member in cross functional developmental teams.
- Leadership – As a member of the Global ASAT organization, lead matrixed teams focused on analytical lifecycle of test methods for commercialization with an aim to ensure effective and efficient delivery of our life-enhancing therapies to our patients.
- Travel - 20-40% travel required.
Requirements:
- Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with a minimum of 12+ years of relevant experience for Ph.D., 15+ years for M.S./M.A., or 20+ years for B.S./B.A.
- Extensive experience in analytical method development, validation, method transfer, commercial launch, and analytical lifecycle management of glycoconjugate vaccines preferred. Demonstrated ability to coordinate CDMO activities and direct experience with directing outsourced assay development, stability, and quality control in support of CMC activities.
- Leadership experience in analytical development, QC, ASAT or MSAT in supervisory and/or matrixed team roles.
- Able to leverage deep technical knowledge in a collaborative manner to establish strategic plans and achieve collective goals.
- 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 directs activities 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: Senior Director, Global Analytical Sciences and Technology (ASAT) Lead
Location: San Carlos, CA
Compensation:The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $220,000 – $236,000 (SF Bay Area). Salary ranges for non-California locations may vary. Vaxcyte, Inc. 825 Industrial Road, Suite 300San 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.