Vaxcyte
Director, Device Development and Commercialization Lead
Vaxcyte, San Carlos, California, United States, 94071
Director, Device Development and Commercialization Lead
Apply for the
Director, Device Development and Commercialization Lead
role at
Vaxcyte .
Vaxcyte is a clinical‑stage vaccine innovation company engineering high‑fidelity vaccines to protect humankind from the consequences of bacterial diseases. Our focus includes invasive pneumococcal disease, Group A Strep, and Shigella, and we are setting a clear path to success.
Our Core Values
RETHINK CONVENTION : Bring creative and intellectual diversity to innovate vaccine delivery.
AIM HIGH : Undertake audacious goals to protect humankind.
LEAD WITH HEART : Lead with kindness‑first, inclusive collaboration.
MODEL EXCELLENCE : Demonstrate integrity, accountability, equality, and clarity.
Summary VAX‑31 is a complex biological product with 31 drug substances in an adjuvanted suspension drug product (DP). It requires a pre‑filled syringe (PFS) combination product for clinical and commercial use. The incumbent will drive this combination product through development and regulatory stage gates, managing a cross‑functional team and ensuring regulatory compliance, especially in the vaccine space.
Essential Functions
Lead combination device development activities from clinical development through commercialization.
Guide the DP team on technical/CMC requirements for 21 CFR Part 4 and Part 820.3 compliance.
Develop design control documents and maintain the design history file (DHF) and Device Master Record (DMR).
Collaborate with cross‑functional teams and external partners to execute device‑specific plans.
Manage suppliers, testing labs, and Human Factors Engineering partners for design verification and validation.
Advise on late‑stage development strategies for process characterization and PPQ campaigns.
Support tech transfers of processes to CMOs.
Design and execute submission strategies for device dossier components and support regulatory CMC activities.
Requirements
Ph.D. with ≥10 years, M.S. with ≥12 years, or B.S. with ≥16 years of leadership in injectable combination product development.
Experience leading device development projects in a cross‑functional matrix organization from concept through commercialization.
Proven design control program execution for biological molecules in combination products, preferably PFS.
Preferred experience with PCV/adjuvanted vaccines.
Experience manufacturing within GxP environments or via CMOs.
Late‑stage DP development, PPQ protocol design, risk assessment, critical parameter identification, and validation experience.
Track record of working across teams to execute the design control process.
Strong scientific leadership, critical thinking and data presentation.
Lead, mentor and develop the team on device development best practices.
Flexibility, organization, and learning agility for multiple projects.
Strong interpersonal and communication skills.
Reports to:
Executive Director of Formulation & Drug Product Development
Location:
San Carlos, CA
Compensation The compensation package includes a competitive salary, comprehensive benefits, and an equity component.
Salary Range:
$219,000 – $256,000 (SF Bay Area). Salary ranges for non‑California locations may vary.
We are an equal‑opportunity employer. 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.
Seniority Level
Director
Employment Type
Full‑time
Job Function
Other
#J-18808-Ljbffr
Director, Device Development and Commercialization Lead
role at
Vaxcyte .
Vaxcyte is a clinical‑stage vaccine innovation company engineering high‑fidelity vaccines to protect humankind from the consequences of bacterial diseases. Our focus includes invasive pneumococcal disease, Group A Strep, and Shigella, and we are setting a clear path to success.
Our Core Values
RETHINK CONVENTION : Bring creative and intellectual diversity to innovate vaccine delivery.
AIM HIGH : Undertake audacious goals to protect humankind.
LEAD WITH HEART : Lead with kindness‑first, inclusive collaboration.
MODEL EXCELLENCE : Demonstrate integrity, accountability, equality, and clarity.
Summary VAX‑31 is a complex biological product with 31 drug substances in an adjuvanted suspension drug product (DP). It requires a pre‑filled syringe (PFS) combination product for clinical and commercial use. The incumbent will drive this combination product through development and regulatory stage gates, managing a cross‑functional team and ensuring regulatory compliance, especially in the vaccine space.
Essential Functions
Lead combination device development activities from clinical development through commercialization.
Guide the DP team on technical/CMC requirements for 21 CFR Part 4 and Part 820.3 compliance.
Develop design control documents and maintain the design history file (DHF) and Device Master Record (DMR).
Collaborate with cross‑functional teams and external partners to execute device‑specific plans.
Manage suppliers, testing labs, and Human Factors Engineering partners for design verification and validation.
Advise on late‑stage development strategies for process characterization and PPQ campaigns.
Support tech transfers of processes to CMOs.
Design and execute submission strategies for device dossier components and support regulatory CMC activities.
Requirements
Ph.D. with ≥10 years, M.S. with ≥12 years, or B.S. with ≥16 years of leadership in injectable combination product development.
Experience leading device development projects in a cross‑functional matrix organization from concept through commercialization.
Proven design control program execution for biological molecules in combination products, preferably PFS.
Preferred experience with PCV/adjuvanted vaccines.
Experience manufacturing within GxP environments or via CMOs.
Late‑stage DP development, PPQ protocol design, risk assessment, critical parameter identification, and validation experience.
Track record of working across teams to execute the design control process.
Strong scientific leadership, critical thinking and data presentation.
Lead, mentor and develop the team on device development best practices.
Flexibility, organization, and learning agility for multiple projects.
Strong interpersonal and communication skills.
Reports to:
Executive Director of Formulation & Drug Product Development
Location:
San Carlos, CA
Compensation The compensation package includes a competitive salary, comprehensive benefits, and an equity component.
Salary Range:
$219,000 – $256,000 (SF Bay Area). Salary ranges for non‑California locations may vary.
We are an equal‑opportunity employer. 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.
Seniority Level
Director
Employment Type
Full‑time
Job Function
Other
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