Manager, Drug Product Manufacturing at Vertex Pharmaceuticals
Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed at other serious and life-threatening diseases.
Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and commercial offices in the United States, Europe, Canada and Australia. For four years in a row, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit www.vrtx.com.
The Manager, 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 three significant commercial products in addition to a 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 - Lead 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
- Conduct process data trending and present summary to management
- Champion continuous process improvement activities, as neede
- Manufacturing technology - Direct due diligence and technology transfer activities associated with enabling both 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 provide technical 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.
In order to succeed in this role, the candidate must be an excellent collaborator and a 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. Experience with spray dried dispersion technology (and its related processes and unit operations) is a plus.
- Minimum Qualifications:
- Degreed in an engineering discipline: BS and 5+ years, MS 3+ years or PhD with 2+ 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 spray dried dispersions a plus.
- Proven ability to solve complex technical and equipment qualification challenges using a rational, scientific approach
- Proficiency with Quality by Design (QbD) concepts and designed experiments required.
- Familiarity with statistical process control (SPC), complex data analysis, mathematical modeling and optimization software (like Matlab, JMP, etc.) preferred.
- 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, including process validation experience
- Willingness and Ability to travel up to 30% of the time.
- Experience with cleaning validation
- Experience with commercial manufacturing of biologics and/or inhalation products is a definite plus
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.