Vaxcyte · 12 hours ago
Director, Device Development and Commercialization Lead
San Carlos, CA
Full-time
Onsite
Director/Executive
$219K/yr - $256K/yr
10+ years expVaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases. They are seeking a Director to lead combination device development activities through clinical development, tech transfer, and commercialization, ensuring compliance with regulatory requirements and successful execution of device-related plans.
BiopharmaBiotechnologyHealth Care
Responsibilities
Lead combination device development activities through clinical development, tech transfer, commercial manufacturing, registration, launch and post market surveillance
Guide the DP team on the necessary technical/CMC requirements for compliance with 21 CFR Part 4 and Part 820.3 and implement into the Combination Product program plan
Responsible for development of design control documents and maintaining design history file (DHF) and Device Master Record (DMR) for the Vax-31 vaccine product
Collaborate with internal cross-functional teams and external partners to develop and execute device specific plans to ensure clinical and launch milestones are met
Manage suppliers, device testing labs and Human Factors Engineering partners for ensure successful design verification and validation studies
Interact with the DP Technical Team and advise on late-stage development strategies for successful execution of Process Characterization studies and PPQ campaigns
Support the DP Technical Team in tech transfers of the process(es) for both late and early-stage programs to CMOs
Design and execute submission strategies for device related dossier components and support regulatory CMC activities
Qualification
Required
PhD with minimum 10+ years, MS with 12+ years, or BS with 16+ years of leadership experience in the development and manufacturing of injectable combination products
Experience leading device development projects in a cross functional matrix organization from concept, development through commercialization
The candidate should have significant experience in managing and executing Design Control programs with biological molecules for combination products (drug device combo), preferably Pre filled Syringe
Experience of manufacturing within GxP environments either directly or through CMOs
The candidate should have a track record of working seamlessly within and across Teams and Organizations to execute the Design Control process
Strong scientific leadership is required: critical thinking, ability to present complex data sets and to independently propose and design follow-up studies
Lead, mentor and develop organization on device development best practices and strategies
High degrees of both flexibility and organizational skills as well as an eagerness and ability to learn in order to effectively navigate multiple projects and timelines
Strong interpersonal skills; ability to communicate effectively both verbally and in written formats are necessary to collaborate effectively with the rest of the Formulation and DP technical team and well as across other teams
Preferred
Experience with PCV/adjuvanted vaccines would be a distinct advantage
Preferred experience in late-stage DP development, designing and executing PPQ protocols, ensuring that drug product manufacturing processes are robust, reproducible, and meet regulatory requirements. This would include conducting risk assessments, identifying critical process parameters, and overseeing process validation activities for suspension DPs
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
2025-12-09
Company data provided by crunchbase