Manager – Technical Operations – Drug Product Manufacturing
| Company | Vertex Pharmaceuticals |
|---|---|
| Location | Boston, MA, USA |
| Salary | $118300 – $177400 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior |
Requirements
- Degree in a pharmaceutical science or engineering discipline: BS and 5+ years, MS 3+ years or PhD with 2+ years of relevant work experience
- Experience in cGMP manufacture of commercial or late phase clinical products
- Process Development of solid oral dosage forms and a sound understanding of the pharmaceutical development process
- Proven ability to solve complex technical and equipment qualification challenges using a rational, scientific approach
- Proficiency with Quality by Design (QbD) concepts and design of experiments required
- Familiarity with statistical process control (SPC), complex data analysis, mathematical modeling and optimization software (like Matlab, JMP, etc.) is a plus
- Demonstrates competency in the principles and practice of cGMPs and associated regulatory considerations in a pharmaceutical environment
- Willingness and Ability to travel up to 30% of the time
Responsibilities
- Develop and execute process validation strategies under quick timelines by working with cross-functional teams including formulation development, analytical, quality, supply chain and regulatory to ensure creative and efficient implementation
- Formulate validation master plans, validation protocols, validation reports, continued process monitoring plans and statistical sampling plans, among other important strategic documents
- Support ongoing internal and external commercial manufacturing activities
- Resolve complex commercial manufacturing issues
- Conduct commercial continued process monitoring and process improvements
- Apply statistical process control to recognize data trends and then implement improvements
- Direct technology transfer to enable both continuous and traditional manufacturing at external suppliers
- Provide technical input to supply chain, quality, and regulatory to formulate global regulatory strategy for qualification of new manufacturing sites
Preferred Qualifications
- Experience with technology transfer and scale up is a plus
- Familiarity with statistical process control (SPC), complex data analysis, mathematical modeling and optimization software (like Matlab, JMP, etc.) is a plus