Sr. Manager, MSAT
San Carlos, California
Protein /
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:
We look forward to welcoming a Senior Manager of Manufacturing Sciences & Technology (MSAT) to advance our mission at Vaxcyte to protect humankind from the consequences of bacterial diseases by developing innovative vaccines. The Sr. Manager will be responsible for leading all facets of Technology Transfer into manufacturing, GMP floor support and Continued Process Verification in accordance with current good manufacturing processes (cGMP). They will also be accountable for developing, managing, and retaining bench strength and technical leadership across the MSAT function through coaching, mentoring, and providing development opportunities to Upstream and Downstream Process Support and Validation teams. This role will liaise with clients and partner organizations to transfer and support new product introduction and development, improvements, troubleshooting, investigation and commercializing of manufacturing processes. The successful candidate will have strong technical, scientific, management and leadership skills, experience in process development through commercialization of biologics, process technology transfer, project management and the ability to influence across functions.
This role will drive the planning, execution and external partner interaction for the MSAT function during technology transfer from clinical through Commercial manufacturing. They will be accountable for all aspects of implementing, validating and monitoring robust and efficient manufacturing processes to produce human clinical trial and commercial products.
Essential Functions:
- The position will manage a team of engineers to support development and drive the technical transfer of vaccine manufacturing processes from clinical to commercialization.
- Is responsible for facility fit assessment, tech transfer activities, coordination of process start-up activities including Engineering Runs, GMP/clinical, PPQ and routine commercial runs, and resulting risk mitigation activities.
- Supports manufacturing activities with active process monitoring and data trending, process deviation resolution, process improvements and scientific expertise in Vaccine Production
- Lead the preparation and review of documentation, compiling and analyzing of process data, deviation investigations, change controls, and CAPAs.
- Review and/or approve internal and CMC documents such as: process descriptions, comparability protocols and reports, justification of specifications, PPQ reports, and relevant sections of regulatory filings (IND, BLA, etc.) and responses. Remain current on Health Authority guidance and expectations.
- Lead phase-appropriate risk-based qualification strategies for manufacturing process steps for in-process testing, release, characterization, and stability, aligned with the goal of commercialization and ensure application of these requirements throughout the product lifecycle.
- Work closely with External Partners (CMO’s), Quality, Regulatory, QC, Supply Chain, and Facilities to ensure successful implementation of cGMP manufacturing processes and testing programs.
- Lead the evaluation, remediation and optimization of methods and processes using statistical tools to ensure safety, quality, delivery and cost control. Enhance productivity by exploring, analyzing, facilitating and leveraging efficiency initiatives.
- Develop resourcing plans and make recommendations on staffing requirements to meet departmental goals.
- Familiarity with and constant attention to the evolving landscape through literature review/publication, conference attendance, industry working group leadership, etc.
- Provide technical direction and support to external manufacturing, including on-the-floor support of process, investigating deviations, leading technical transfer.
Requirements:
- PhD in Biotechnology, Chemical or Pharmaceutical Engineering, or related field, with minimum of 5 years of relevant experience; or
- M.S./M.A. in Biotechnology, Chemical or Pharmaceutical Engineering, or related field, with minimum of 8 years of relevant experience; or
- B.S./B.A. in Biotechnology, Chemical or Pharmaceutical Engineering, or related field, with minimum of 12 years of relevant experience.
- 5+ years in a leadership role of sciences / technology groups in a fast-paced production environment.
- Broad experience in all process areas across multiple operational scales (Upstream cell culture, downstream processing, buffer and media preparation) and ancillary processes (CIP, SIP).
- Proficiency in working with multicultural and cross-disciplinary project teams.
- Good GMP knowledge
- Experience in leading matrix teams, influencing without direct authority, strategic initiatives.
- Excellent organization, planning, problem solving and critical thinking skills.
- Excellent writing, communication and presentation skills.
- Energy and drive (committed, drive for results).
- Willingness to travel up to 25%.
Reports to: Director, Protein Development & Clinical Manufacturing
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $180,000 – $187,000
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.
