Vaxcyte · 1 month ago
Associate Director, Global Drug Substance Commercialization, Critical Raw Materials
Vaxcyte is a clinical-stage vaccine innovation company developing vaccines to protect against bacterial diseases. The Associate Director, Global Drug Substance Commercialization, Critical Raw Materials will lead launch readiness, commercial supply, technical planning, process robustness, regulatory support, and lifecycle management for critical raw materials used in vaccine production. The role coordinates cross-functional and external stakeholders across commercialization, technology transfer, validation, and technical operations.
PharmaceuticalBiotechnologyHealthcareBiopharmaHealth Care
Comp. & BenefitsH1B Sponsor Likely
Responsibilities
**DS Commercialization –** Provide strategic and scientific leadership for eCRM and associated 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 authoring and reviewing 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** 10-20% travel required
Qualification
Required
Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with a minimum of 9+ years of relevant experience for Ph.D., 11+ years for M.S./M.A., or 14+ 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
An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry
10-20% travel required
Preferred
Experience with pneumococcal conjugate vaccines strongly desired
Location: Open to Remote, prefer San Carlos, CA or Raleigh, NC
Benefits
Comprehensive benefits
An equity component
Remote work
Company
Vaxcyte
Develops broad-spectrum vaccines for bacterial diseases.
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
83%
Represents job field similar to this job
Engineering and Development
Management and Executive
Accounting and Finance
Trends of Total Sponsorships
*2026 (4)
2025 (14)
2024 (7)
2023 (5)
2022 (7)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$4.48BKey Investors
CARB-XJanus Henderson Investors,RA Capital ManagementTPG Growth
2026-01-29Post Ipo Equity· $632.5M
2024-09-04Post Ipo Equity· $1.5B
2024-01-30Post Ipo Equity· $862.5M
Leadership Team
Grant Pickering
Co-Founder, CEO, Director
Andrew Guggenhime
President & Chief Financial Officer
Recent News
FierceBiotech
2026-10-08
Company data provided by crunchbase