Senior Engineer, Device Development

Vaxcyte•San Carlos, CA

7d•$165,000 - $192,000•Onsite

About The Position

Vaxcyte is seeking a technically experienced and collaborative individual to join its Device Development Team. This role will lead the development of combination products within the company's portfolio through the necessary development and regulatory stage gates for commercial success and distribution. Initially, the candidate will support the development and regulatory approval of VAX-31, a complex biological vaccine with 31 drug substances presented as an adjuvanted suspension drug product. This complexity necessitates the development of a pre-filled syringe (PFS) combination product for clinical and commercial use, presenting unique challenges for production, handling, and testing. This is a Subject Matter Expert (SME) position for someone experienced in leading technical combination product workstreams for PFS/biologic combination products, including design control requirements and documentation. The role involves close collaboration with various teams (MSAT, CMO, Supply Chain, QC, QA, Clinical, Regulatory, Quality) to ensure device design requirements and testing are met for clinical studies and global marketing submissions, adhering to 21 CFR Part 4 and 21 CFR Part 820.3 compliance. This is a significant opportunity to contribute to a highly complex drug product nearing clinical testing and commercial readiness, impacting millions of lives globally. Experience in the vaccine space, particularly with adjuvanted vaccines, is beneficial.

Requirements

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 of education and/or experience 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 in managing and executing Design Control programs with biological molecules for combination products, preferably PFSs.
Experience manufacturing within GxP environments either directly or through CMO partnerships.
Strong scientific leadership is required, including critical thinking, the ability to present complex data sets, and the ability to independently propose and design follow-up studies.
Strong interpersonal skills, including the ability to communicate effectively in both verbal and in written formats, in order to collaborate effectively within the DP Technical Team and across teams.

Nice To Haves

Experience with pneumococcal conjugate vaccines or other adjuvanted vaccine products would be a distinct advantage.
Preferred experience in late-stage DP development, design and execution of PPQ protocols, and robust, reproducible, regulatory-compliant drug product manufacturing processes. Includes experience conducting risk assessments, identifying critical process parameters, and overseeing process validation activities for suspension DPs.
The candidate should have a track record of working seamlessly within and across teams and organizations to execute Design Control processes.

Responsibilities

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.