Device Development Lead, Combination Products (VAX-31)

Job title: Device Development Lead, Combination Products (VAX-31)

About the Role Vaxcyte is seeking a technically experienced and collaborative professional to join the Device Development Team to lead development of combination products through clinical development, technology transfer, commercial manufacturing, registration, launch, and post-market surveillance. Initially, this candidate will support development and regulatory approval of VAX-31.

What You'll Do

• Lead combination product and device development activities through clinical development, tech transfer, commercial manufacturing, registration, launch, and post-market surveillance.
• Guide the DP Technical Team on the necessary technical/CMC requirements for compliance with 21 CFR Part 4 and 21 CFR Part 820.3, ensuring alignment and integration within established Combination Product program plans.
• Develop and maintain design control documents and maintain the Design History File (DHF) and Device Master Record (DMR) for the VAX-31 PFS product.
• Collaborate with internal cross-functional teams and external partners to execute device-specific plans to ensure program milestones are met.
• Manage suppliers, device testing labs, and Human Factors Engineering partners to ensure successful design verification and validation studies.
• Support the DP Technical Team in existing and new tech transfer activities for both early- and late-stage programs to CMOs.
• Contribute to device-related submission strategies and support regulatory CMC activities.
• Mentor other engineers in the department, potentially leading to management opportunities.
• May act as a device SME in support of complaints, or other investigations.

What We're Looking For

• PhD with 5+ years, Masters with 10+ years, or BS with 13+ years of relevant industry experience in the development and manufacturing of injectable combination products; other combinations may be considered.
• Experience leading device development projects in a cross-functional matrix organization from early concept through late-stage development and commercialization.
• Significant experience managing and executing Design Control programs with biological molecules for combination products, preferably PFSs.
• Experience with pneumococcal conjugate vaccines or other adjuvanted vaccines would be a distinct advantage.
• Experience manufacturing within GxP environments either directly or through CMO partnerships.
• Preferred experience in late-stage DP development, design and execution of PPQ protocols, and robust, reproducible, regulatory-compliant drug product manufacturing processes.
• Experience conducting risk assessments, identifying critical process parameters, and overseeing process validation activities for suspension DPs.
• Track record of working seamlessly within and across teams and organizations to execute Design Control processes.
• Strong scientific leadership, critical thinking, data presentation skills, and ability to independently propose and design follow-up studies.
• Strong interpersonal skills.

Nice to Have

• Experience in the vaccine space, particularly adjuvanted vaccines, would be beneficial.