Senior Device Development Lead, Combination Products (PFS)

Vaxcyte, Inc; San Carlos (CA); On-site; USD 165,000 - 192,000; Full time

Benefits offered by this job

Equity component

Job summary

Vaxcyte, Inc. is seeking a technically experienced leader to drive the development of combination products for the VAX-31 program.

The role requires coordinating across MSAT, CMO, Supply Chain, QC, QA and Clinical teams to ensure device design requirements are met for clinical studies and global submissions. The candidate will oversee design control, DTQ/CMC activities, and participate in late-stage development with a focus on regulatory-compliant documentation and successful tech transfers to

Qualifications

• PhD with 5+ years in development/manufacturing of injectable combination products or equivalent.
• Masters with 10+ years, or BS with 13+ years of relevant experience in DP development and manufacturing.
• Experience leading device development projects in cross-functional matrix environments.

Responsibilities

• Lead combination product and device development through clinical development, tech transfer, commercialization and post-market surveillance.
• Guide DP Technical Team on 21 CFR Part 4 and 21 CFR Part 820.3 compliance within CP program plans.
• Develop and maintain DHF and DMR for the VAX-31 PFS product and ensure robust design verification/validation studies.

Skills

Scientific leadership

Cross-functional collaboration

Verbal & written communication

Education

PhD with 5+ years

Masters with 10+ years

BS with 13+ years

Job description

Vaxcyte, Inc. is seeking a technically experienced leader to drive the development of combination products for the VAX-31 program.

The role requires coordinating across MSAT, CMO, Supply Chain, QC, QA and Clinical teams to ensure device design requirements are met for clinical studies and global submissions. The candidate will oversee design control, DTQ/CMC activities, and participate in late-stage development with a focus on regulatory-compliant documentation and successful tech transfers to