Competitive remuneration; annual incentive plan bo...
Onsite
8+ years in quality role cgmp environment
5+ years managing people
5+ years regulatory experience biopharma
This role is critical for ensuring the St. Louis Biologics site remains a trusted CDMO partner by delivering regulatory excellence
Job Summary
This role is critical for ensuring the St. Louis Biologics site remains a trusted CDMO partner by delivering regulatory excellence.
The position involves serving as the primary contact for Site Regulatory Affairs and collaborating on lifecycle management activities across multiple client programs.
Thermo Fisher Scientific offers competitive remuneration, an annual incentive plan bonus, healthcare, and relocation assistance.
Matching Summary
This role is critical for ensuring the St. Louis Biologics site remains a trusted CDMO partner by delivering regulatory excellence.
Salary
Competitive remuneration; Annual incentive plan bonus; Healthcare and employee benefits
Skills & Requirements
Must-have
8+ years in Quality role cGMP environment
5+ years managing people
5+ years regulatory experience biopharma
Experience with FDA EMA global requirements
Authoring CMC sections for IND/BLA submissions
Nice-to-have
Outstanding leadership and collaboration skills
Proven ability to influence cross-functional stakeholders
Strong communication abilities in dynamic team
Key Requirements
Bachelor's degree in scientific field
Must be legally authorized to work in US without sponsorship
Pass comprehensive background check including drug screening
Work Rights
Must be legally authorized to work in US without sponsorship