This job is closed
We regret to inform you that the job you were interested in has been closed. Although this specific position is no longer available, we encourage you to continue exploring other opportunities on our job board.
Vertex Pharmaceuticals - Boston, MA
posted 2 months ago
About the position
The Technical Operations Drug Product team at Vertex is seeking a skilled professional to facilitate the rapid commercialization of new pharmaceutical products using both traditional and continuous manufacturing technologies. This role involves collaborating with cross-functional teams to develop and execute process validation strategies, support commercial production, and manage technology transfer to external suppliers, all within a Quality by Design (QbD) framework.
Responsibilities
- Develop and execute process validation strategies under quick timelines.
- Work with cross-functional teams including formulation development, analytical, quality, supply chain, and regulatory.
- Formulate validation master plans, validation protocols, and validation reports.
- Support ongoing internal and external commercial manufacturing activities.
- Resolve complex commercial manufacturing issues and conduct continued process monitoring.
- Apply statistical process control to recognize data trends and implement improvements.
- Direct technology transfer to enable continuous and traditional manufacturing at external suppliers.
- Provide technical input to supply chain, quality, and regulatory for global regulatory strategy.
Requirements
- Degree in a pharmaceutical science or engineering discipline (BS with 5+ years, MS with 3+ years, or PhD with 2+ years of relevant work experience).
- Experience in cGMP manufacture of commercial or late phase clinical products.
- Experience with technology transfer and scale up is a plus.
- Process Development of solid oral dosage forms and understanding of the pharmaceutical development process.
- Proven ability to solve complex technical and equipment qualification challenges.
- Proficiency with Quality by Design (QbD) concepts and design of experiments.
- Familiarity with statistical process control (SPC) and complex data analysis.
Nice-to-haves
- Experience with mathematical modeling and optimization software (like Matlab, JMP, etc.).
- Strong collaboration and teamwork skills.
Benefits
- Flexible work options (Hybrid or On-Site).
- Commitment to equal employment opportunity and non-discrimination.
- Reasonable accommodations for qualified individuals with disabilities.
