Sr. Director, Global Drug Product Commercialization Lead

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 Drug Product (DP) Commercialization lead develops and facilities DP manufacturing (formulation, fill/finish and container closure) and DP analytical (tech transfer and lifecycle) 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 DP processes/analytical characterization 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 Process Leadership to MSAT DP functions and relevant DP cross-functional teams 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 DP strategy.

Manufacturing Science and Technology (MSAT) 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 Vaxcyte, Inc. Page 2 of 4 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).

The range of activities will include DP technology transfer support, process characterization experiments in support of validation, process improvement, evaluation of novel process technologies, and investigation of process related manufacturing issues, ensuring continuous improvement in process robustness throughout the product life cycle etc. The MSAT organization will also include analytical sciences and technology (ASAT) for analytical technology transfer support and DS/DP characterization. The ASAT team will support commercial operations as well as the quality chemistry (QC) on all aspects of analytical methodology and heightened characterization studies.
Essential Functions:DP Commercialization - Provide strategic and scientific advice for internal and external stakeholders and ensure successful execution of launch plans and post-launch commercial activities.Organization development - Build a strong and scalable MSAT DP Process organization (including DP ASAT) for the global network with special focus on conjugation science and technologies.Process robustness - Optimize the use of resources (human, and laboratory equipment) across the organization in support of DP lifecycle. Product Characterization - provide analytical support for in-process, release and heightened characterization across the organization in support of the DP lifecycle.Technical agenda - The leader will also be responsible for developing and managing a network-level technical agenda in support of each DP life-cycle planInterface - Manage the technical interface with Process Development, 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 network to drive the successful development and commercial launch of pipeline productsStewardship - Ensure stewardship for key modalities (Drug Products), with sufficient process oversight and expertise for each process stepTech-transfer new technologies - Ensure robust processes exist to support technical transfers and integration of new technologiesSupport technical services - Support of our internal and external manufacturing network, including materials management and data analyticsProcess validation and comparability - Provide leadership for the execution of process validation and process comparability activities. Effectively communicate the scientific and commercial rationale for DP processes to the Manufacturing organization for commercializationRegulatory - 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 DP processes to the Boards of Health for regulatory submissions for commercializationCommunicate - Effectively and efficiently communicate process performance to key stakeholders (internal-facing and external-facing)DP thought partner - Serve as a thought partner with Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering colleagues.Leadership - Contribute as Global MSAT DP 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.Travel % travel required.
Requirements: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 12-15 years of relevant biotechnology or pharmaceutical industry (Process Development, MSAT, Operations, Quality, Supply Chain). At least 12 years of leadership experience in MSAT or other Process Development function in a Supervisory, People Leader role. Extensive experience in tech transfer, commercial launch, and lifecycle management of glycoconjugate vaccines preferred.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, innovative ideas that will stretch the organization and push the boundaries within the industry. The ability to effectively balance the desire/need for broad change with an understanding of how much change the organization is capable of handling, to create realistic goals and implementation plans that are achievable and successful.
Executing for Results:The ability to set clear and challenging goals while committing the organization to improved performance, tenacious and accountable in driving results. Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations. A leader who will be able to take calculated risks founded on data and input from others to foresee possible threats or unintended circumstances from decisions. A leader who is viewed by others as having a high degree of integrity and forethought in his/her approach to making decisions; the ability to act in a transparent and consistent manner while always considering what is best for the organization.
Leading Teams:The ability to attract and recruit top talent, motivate the team, delegate effectively, celebrate diversity within the team, and manage performance; widely viewed as a strong developer of others. The ability to persevere in the face of challenges and exhibit a steadfast resolve and relentless commitment to higher standards, which commands respect from colleagues.A leader who is self-reflective and aware of his/her own limitations; leads by example and drives the organization's performance with an attitude of continuous improvement by being open to feedback and self-improvement.
Relationships and Influence:Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively. An ability to inspire trust and followership in others through compelling influence, powerful charisma, passion in his/her beliefs, and active drive. Encourages others to share the spotlight and visibly celebrates and supports the success of the team. Creates a sense of purpose/meaning for the team that generates followership beyond his/her own personality and engages others to the greater purpose for the organization. Able to skillfully leverage deep technical knowledge in a collaborative manner to achieve collective goals.
Reports to: Vice President, MSAT

Location: San Carlos, CA

Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.

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