Summary:

Vaxcyte is looking for a technically experienced and collaborative individual to join our Device Development Team to lead development of combination products in our portfolio through the development and regulatory stage gates required for commercial success and distribution. Initially, this candidate will support development and regulatory approval of VAX-31.

About VAX-31: VAX-31 is an extremely complex biological vaccine whereby numerous (31) Drug Substances are presented as an adjuvanted suspension Drug Product (DP). The complexity of the DP necessitates careful consideration for development of a pre-filled syringe (PFS) combination product for clinical and commercial use. The VAX-31 DP is a suspension, which generates a unique set of challenges for production, handling, and testing.

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. As a core member of the DP Technical Team, they will work closely with MSAT, CMO, Supply Chain, QC, QA and Clinical teams to ensure the appropriate Device Design requirements, including formal verification testing, are met for the product’s use in clinical studies and global marketing submissions. They will work closely with the Regulatory and Quality teams to ensure the appropriate 21 CFR Part 4- and 21 CFR Part 820.3-compliant documentation is produced to support clinical studies, marketing applications, and continued commercial life cycle management.

This is a unique opportunity to be involved in arguably the most complex Drug Product to enter clinical testing and commercial readiness and be a crucial part of late-stage enablement and long-term commercial success, positively impacting millions of lives globally. Because of these complexities, experience in the vaccine space, particularly adjuvanted vaccines would be beneficial.

Essential Functions:

• 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.

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.
• 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.
• 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.
• 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.