Process Engineering Senior Technical Specialist, Drug Product Manufacturing

Job Description

The Sr. Technical Specialist, Drug Product Manufacturing is an exciting opportunity to join Vertex's growing Technical Operations team and facilitate rapid commercialization of new products utilizing continuous manufacturing technology while working with first-in-class commercial operations and external suppliers in an industry-leading Quality by Design (QbD) environment. Vertex Pharmaceuticals currently has five significant commercial products in addition to a very robust pipeline with multiple new molecules in various stages of clinical development. The successful candidate will have the opportunity to add significant value in three areas:

• Commercial production support - Participate in important cross-functional initiatives involving resources from across the Vertex organization to
  • Support ongoing internal and external commercial manufacturing activities
  • Resolve complex commercial manufacturing issues being mindful of Supply, Quality, and Regulatory constraints
  • Oversee quarterly process data trending activities and preparation of quarterly management review presentations
  • Champion continuous process improvement activities, as needed;

• Manufacturing technology - Direct due diligence and technology transfer activities associated with enabling new continuous and traditional manufacturing capabilities and capacity at external suppliers. In this role, the candidate will work with Supply Chain, Quality, and Regulatory organizations to guide technical and provide input into the global regulatory strategy associated with the qualification of new manufacturing sites.
• Process validation and new product launch - Develop appropriate process validation strategies and statistical product sampling plans that provide the appropriate data and demonstration of process control to meet GMP requirements.

Minimum Qualifications:

• Degree in an engineering discipline: BS and 4+ years, MS 2+ years or PhD with 0+ years of relevant work experience
• Experience in technology transfer, scale-up, and late phase clinical development
• Process Development experience in solid oral dosage forms and a sound understanding of the pharmaceutical development process
• Experience with Quality by Design (QbD) concepts, DoE, statistical process control (SPC) and complex data analysis
• Must be a committed team player and collaborator
• Effective written and verbal communication skills
• Ability to multitask to effectively manage multiple activities and projects
• Demonstrates competency in the principles and practice of cGMPs and associated regulatory considerations in a pharmaceutical environment, including process, equipment, and facility validation experience
• Ability to travel up to approximately 20 - 50%

Flex Designation:

Flex Eligibility Status:

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com