Vaxcyte

Senior Engineer, Device Development

San Carlos, California, United States · Senior

Sponsorship not specified$165k-$192kDetected 14 days ago

Supply ChainClinical TrialsLeadershipCommunicationCollaborationCritical ThinkingGxP

About the role

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked.
Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning.
Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

Lead combination product and device development activities through clinical development, tech transfer, commercial manufacturing, registration, launch, and post-market surveillance.
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
May act as a device SME in support of complaints, or other investigations.

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.
Experience leading device development projects in a cross-functional matrix organization from early concept through late-stage development and commercialization.
The candidate should have significant experience in managing and executing Design Control programs with biological molecules for combination products, preferably PFSs.
Experience with pneumococcal conjugate vaccines or other adjuvanted vaccine products would be a distinct advantage.
Experience manufacturing within GxP environments either directly or through CMO partnerships.
The candidate should have a track record of working seamlessly within and across teams and organizations to execute Design Control processes.
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.
This is an SME position suited for someone who has experience in leading the technical combination product workstream for a PFS/biologic combination product.
Experience with combination product design control requirements and generation of associated documentation is required.
Because of these complexities, experience in the vaccine space, particularly adjuvanted vaccines would be beneficial.

Includes experience conducting risk assessments, identifying critical process parameters, and overseeing process validation activities for suspension DPs.

$165,000 - $192,000 (SF Bay Area).
The compensation package will be competitive and includes comprehensive benefits and an equity component.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

This listing is sourced directly from Vaxcyte's careers page and normalized into a canonical job model.