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:

1. 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.
2. AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
3. LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
4. MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality, and clarity across communications and decision-making.

Summary:

Vaxcyte

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.

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