Vaxcyte · 2 weeks ago
Senior Manager, Global Drug Substance Commercialization, Critical Raw Materials
San Carlos, CA
Full-time
Onsite
Senior Level
$163K/yr - $190K/yr
5+ years expVaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases. The Senior Manager for Drug Substance Commercialization is responsible for launch readiness and commercial supply of critical raw materials for glycoconjugate vaccines, focusing on technical launch planning and execution while ensuring effective communication with stakeholders and regulatory agencies.
BiopharmaBiotechnologyHealth Care
Responsibilities
DS Commercialization – Provide strategic and scientific leadership for critical raw materials with internal and external stakeholders and ensure successful execution of launch plans and post-launch commercial activities
Process robustness – Continuously improve process understanding and process robustness by putting systems in place to monitor, trend, and optimize operations
Interface - Collaboration with cross-functional teams across the network, including Regulatory, Process Development, Quality, Supply Chain, Procurement, and DS Operations, to drive the successful development and commercial launch of carrier proteins for pipeline products. Provides 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
Tech-transfer new technologies - Ensure robust processes exist to support technical transfers and integration of new technologies
Support technical services - Support of our internal and external manufacturing network, including materials management and data analytics
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 DS processes to the Boards of Health for regulatory submissions for commercialization
Communicate - Effectively and efficiently communicate process 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 lead others through complex situations
Leadership - Contribute as member of the DS Commercial MSAT team, with an aim to ensure effective and efficient delivery of our life-enhancing therapies to our patients
Travel - 10-30% travel required
Qualification
Required
Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with a minimum of 5+ years of relevant experience for Ph.D., 8+ years for M.S./M.A., or 12+ years for B.S./B.A
Broad experience in protein processes, including bacterial fermentation, recovery, and purification across multiple operational scales
Leadership experience in MSAT or Process Development in supervisory and/or matrixed team roles
Able to leverage deep technical knowledge in a collaborative manner to achieve collective goals
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 independently identifies and implements effective steps and 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
Preferred
Experience with cell free protein synthesis and associated critical raw materials desired
An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry
Benefits
Comprehensive benefits
An equity component
Company
Vaxcyte
Vaxcyte focuses on developing vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide.
201-500 employees
H1B Sponsorship
Vaxcyte has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (7)
2023 (5)
2022 (7)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$3.85BKey Investors
CARB-XTPG GrowthAbingworth
2024-09-04Post Ipo Equity· $1.5B
2024-01-30Post Ipo Equity· $862.5M
2023-04-19Post Ipo Equity· $500M
Leadership Team
Andrew Guggenhime
President & Chief Financial Officer
Jeff Fairman
Founder and Vice President, Research
Recent News
Pharma Letter
2026-01-25
2026-01-23
Company data provided by crunchbase