Associate Director, Msat, Proteins

**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**:
Vaxcyte is looking for an energetic and talented individual to join the Manufacturing Science and Technology (MSAT) team in the role of Proteins Associate Director. The incumbent will support the microbial manufacturing operations from commercial readiness through PPQ and ongoing commercial production, onsite at CMO service providers, with the primary responsibility to provide technical and operational support of manufacturing operations that ensure robust and efficient manufacturing processes. This position will primarily be located in Visp, Switzerland.

This is an exciting opportunity to join an outstanding team, with a mission to establish an onsite MSAT group supporting late-stage clinical manufacture, launch, and commercial operations.
- A skilled scientist or process engineer with expertise in:

- Protein production, fermentation, and synthesis.

product recovery and purification techniques.
- A strong technical leader experienced in providing mentoring and training for staff members.
- An exceptional team player who works seamlessly with others, speaks up, and remains focused on achieving the best results to attain company goals.
- The ability to analyze data and communicate conclusions, decisions and recommendations concisely to key stakeholders.
- A strong sense of ownership and accountability; commitment to Vaxcyte’s mission of protecting humankind.

**Essential Functions**:

- Work cross functionally with program management, process development, quality, facilities, regulatory, finance, logistics, clinical supply, and CMO / supplier management to ensure manufacture under GMP of different cell extract and lysates as well as carrier protein production required for Vaxcyte’s vaccine portfolio.
- Oversight of CMO service provider(s) to ensure delivery of commercial readiness, process validation, and commercial stage manufacturing campaigns.
- Build a Proteins MSAT team to support European CMO operations.
- Enable MSAT proteins team participation in technology transfer, equipment/technology procurement and qualification, late-stage process characterization, process validation, and deviation and deficiency investigations and troubleshooting.
- Lead all aspects of and engage in the planning, design, execution, and documentation of carrier protein manufacturing process Investigations and CAPAs.
- Support the process to select new CMOs and suppliers.
- Leverage literature, industry/regulatory guidance, and practical experience to perform work and influence CMC strategies
- Recommend and implement new technology that advances knowledge and productivity within the department. Drive continuous improvement.
- Author and review technical reports, manufacturing documents, regulatory submissions, and publications
- Present at department, project team, and senior management meetings. May present externally at scientific conferences.

**Requirements**:

- PhD in Bio/Chemical Engineering or Microbiology/Chemistry/Biochemistry with 7+ years of relevant Pharma/Biotech industry experience, or Master’s degree in Bio/Chemical Engineering or Microbiology/Chemistry/ Biochemistry with 12+ years of relevant Pharma/Biotech industry experience.
- Experience with Vaccine manufacturing operations preferred.
- Strong experience in Drug Substance Manufacturing under GMP regulations required. Understanding of Quality systems. Experience in Drug Substance manufacturing equipment specification and qualification preferred.
- Strong scientific or technological (process engineering) background and hands-on experience with biochemical reaction, product recovery, and purification processes. Commercial manufacturing experience preferred.
- Deep knowl