Associate Director, MSAT Bioconjugates
Visp
Manufacturing and Supply Chain /
Full-time /
Hybrid
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:
Vaxcyte is looking for an energetic and talented individual to join the Manufacturing Science and Technology (MSAT) team in the role of Bioconjugates Associate Director. The incumbent will support the microbial and conjugation 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 position will require the candidate to manage the highly complex microbial and connected conjugation manufacturing processes for Vaxcyte’s vaccine portfolio. This role will be responsible for developing the organization and implementing the processes and systems necessary for advanced MSAT capabilities at Vaxcyte.
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. The successful candidate will have the following skills and qualities:
· A skilled scientist or process engineer with expertise in conjugation chemistry, molecule activation, and buffer exchange manufacturing operations and product recovery and purification
· 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 protein-polysaccharide conjugate Drug Substances required for Vaxcyte’s vaccine portfolio.
- Oversight of CMO servicenprovider(s) to ensure delivery of commercial readiness, process validation, and commercial stage manufacturing campaigns.
- Build a Bioconjugation MSAT team to support European CMO operations.
- Enable MSAT DS 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 DS manufacturing process Investigations and CAPAs.
- Drive continuous improvement in DS manufacturing processes through technological innovation and application of first principles in process engineering.
- 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 knowledge of protein-polysaccharide conjugation principles, bioreactor systems and process analytics/control systems
- Sound knowledge of:
- product recovery unit operations such as homogenization/microfluidization, centrifugation, and depth filtration.
- product purification unit operations such as chromatography, UF/DF TFF, and precipitation.
- process analytics/control systems.
- Strong ability in troubleshooting equipment/technology and process. Adept at FMEA. Excellent analytic skills. Experience in Investigations and development and implementation of CAPAs preferred.
- Experience with facility fit assessment, facility start-up, technology transfer, process validation, and scale-down studies implementing DOE desired.
- Strong interpersonal and leadership skills. Ability to communicate effectively both verbally and in written formats. Experience with Cross-Functional teams and managing direct reports.
- Proven technical leadership skills including strong project management skills.
- Fluency in spoken and written English is mandatory.
Reports to: Director, MSAT
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Send resumes to:
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.
