The role is responsible for implementing and overseeing the processes and programs for Biotherapeutics (BTx) GMP R&D pipeline programs
Job Summary
The role is responsible for implementing and overseeing the processes and programs for Biotherapeutics (BTx) GMP R&D pipeline programs.
This position requires solid understanding of compliance regulations, process validation, Quality by Design concepts, and quality systems as they relate to manufacturing, testing, stability, scale-up, and development of cell culture/fermentation and purification processes.
The annual base salary for this position ranges from $124,400.00 to $207,400.00.
Matching Summary
The role is responsible for implementing and overseeing the processes and programs for Biotherapeutics (BTx) GMP R&D pipeline programs.
Salary
Base: $124,400.00 - $207,400.00; Bonus/Equity: 17.5% bonus target; Benefits: Comprehensive and generous benefits and programs
Skills & Requirements
Must-have
Biotherapeutics (BTx) GMP R&D pipeline
Quality oversight for clinical trial material
GMP compliance and Quality decisions
Collaboration with CMOs and Pharm Sci sites
Process validation and Quality by Design
Nice-to-have
Innovative use of communication tools
Strengthening quality culture globally
AI tools for problem solving
Key Requirements
Bachelor's degree with 6+ years experience OR Master's degree with 5+ years experience OR PhD with 1+ years experience
4+ years' experience in BTx Portfolio project overseeing PSPT and Co-Dev teams