Sr. Director, Global Analytical Sciences and Technology (ASAT) Lead
Vaxcyte, Inc.
2024-09-20 19:38:57
San Carlos,
California,
United States
Job type: fulltime
Job industry: Science & Technology
Job description
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:
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.
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.
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 Global Analytical Sciences and Technology (ASAT) Commercialization lead develops and facilitates analytical (development, tech transfer and lifecycle of commercial manufacturing) strategy, program prioritization, and execution to drive the successful launch of products. This role also provides leadership to ensure that the teams are equipped to effectively communicate the scientific and commercial rationale for drug substance and drug product analytical testing to the manufacturing and quality organization and to the Boards of Health for regulatory submissions for commercialization. This role focuses on technical launch planning and execution by bringing best-practices and coordinating cross-functional efforts to ensure necessary steps are started at the appropriate times and resourced optimally. Works in alignment with network organization to ensure on-time execution and appropriate planning for commercial lifecycle management.
Reporting into the Vice President of Global MSAT, the Senior Director (SD) position will be responsible for providing analytical leadership to all commercial DSI, DS and DP functions across the network. The SD will be a key member of the Global Manufacturing team where they will coordinate and collaborate on overall program strategy, with primary responsibility and accountability for the analytical strategy.
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:
- The ASAT group will focus on developing, qualifying/validating, and optimizing analytical methods/technologies used in the commercial manufacturing process and through its life cycle. The ASAT SD will be accountable for the success of the commercial analytical control strategy (release and characterization) including establishing the analytical methods. The ASAT team will support commercial operations as well as the quality chemistry (QC) on all aspects of analytical methodology and heightened characterization studies. The ASAT SD will have oversight of analytical control strategy rationale which are expected to meet the Boards of Health Standards set for vaccine safety and efficacy.
- Commercialization -Provide strategic and scientific advise for internal and external stakeholders and ensure successful execution of launch plans and post-launch commercial activities. Implement 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 - The leader will also be responsible for developing and managing a network-level technical agenda in support of analytical life-cycle plan. Provide technical support for complex analytical challenges. Tech-transfer new technologies - Ensure robust processes exist to 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, etc.). 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.
- Organization development - Build a strong and scalable ASAT organization for the global network with special focus on conjugation science and technologies. Optimize the use of resources (CMO or internal or external supplier, laboratory equipment or staff) across the organization in support of DS/DP lifecycle.
- Interface - Manage the technical interface with AD, QC and Commercial organizations providing technical representation into initial technology transfer, product launch, product lifecycle, to the end of life/product retirement and for defining/developing the next generation of production technologies. 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.
- Supplier Management - Drive technical relationship with key analytical suppliers for commercialization and late-stage clinical methods and testing.
- Stewardship - Ensure stewardship for key modalities with sufficient process oversight and expertise for each process step. Serve as a technical expert and aid in analytical investigations and troubleshooting.
- Communicate - Effectively and efficiently communicate process performance to key stakeholders (internal-facing and external-facing).
- 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.
- Travel - 10-30% travel required.
- PhD in Biological science (Biotechnology, Biochemistry), or MS Degree/Bachelor in Biochemical Engineering.
- MS or Ph.D. degree in Chemical or Biochemical Engineering, Chemistry, Biochemistry, Analytical Chemistry or related discipline is required.
- Extensive experience in complex multivalent conjugation formulation and analytical technology highly preferred. Minimum of 14 years of relevant biotechnology or pharmaceutical industry (chemistry, analytical or quality control QC ). At least 12 years of leadership experience in ASAT or MSAT or QC or Analytical Development function in a Supervisory, People Leader role.
- Extensive experience in tech transfer, commercial launch, and 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.
- The ability to create and articulate an inspiring vision for the global organization. The inclination 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 . click apply for full job details