Vertex’s Technical Operations Drug Product team has an exciting and challenging opportunity for you to facilitate rapid commercialization of new products utilizing traditional and continuous manufacturing technology in our industry-leading Quality by Design (QbD) environment. Vertex has four significant commercial products in addition to multiple new molecules in various stages of clinical development. The successful candidate will have the opportunity to add significant value in several areas:
Process Validation and New Product Launch
- 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. This includes the opportunity to 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.
- The candidate must be an excellent collaborator and proven technical leader with experience in a cGMP pharmaceutical drug product manufacturing environment. The successful candidate will have a solid background in solid oral dosage form manufacturing.
- 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. Experience with technology transfer and scale up is a plus.
- 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.
- Must be a committed team player and collaborator
- 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.
- Experience with Process Validation
- Experience with commercial manufacturing of biologics and/or parenteral products is a plus but not required.