Process Dev Engineering Senior Scientist

Job Description

General Summary:

The incumbent will work cross-functionally with colleagues in the BSMO/CMSC, Regulatory, Quality and R&D of Vertex on the design of processes and technologies required to successfully commercialize an exciting and diverse portfolio of innovative pipeline programs. The Process Dev Engineering Senior Scientist will be part of a team working to design and develop robust, scalable, well characterized, and economical upstream processes for clinical and commercial manufacturing of biologics. The successful candidate will interact with internal product development groups and with Vertex's network of external CMOs/contract labs.

Key Duties and Responsibilities:

• Apply a fundamental understanding of mammalian cell culture operations to support technology transfer and scale-up of clinical/commercial manufacturing processes.
• Use comprehensive understanding of chemical engineering principles for the scale up of unit operations from bench to commercial scale.
• Provide technical leadership in solving clinical and commercial drug substance process issues involving equipment, scale, and raw materials. Evaluate process capabilities to develop and implement process and yield improvement opportunities.
• Provide floor support/person-in-plant for manufacturing activities during development and GMP campaigns (travel will be required).
• Use Design of Experiments (DOE) with subsequent statistical analysis of data to establish robust process parameters and specifications.
• Perform process/product risk assessments (FMEA, QbD) and prepare relevant reports.
• Provide content and author relevant sections in regulatory submissions.
• Represent Upstream MSAT on one or more internal project teams and on CMO/external project teams to enable successful project deliverables.
• Collaborate within CMC teams as an Upstream SME and actively contribute to deliverables and engage in team discussion on issue resolution.
• Mentor and train junior scientists and engineers, fostering a collaborative and innovative work environment.
• This position will have travel up to 20%.

Knowledge and Skills:

• Strong fundamental knowledge and subject matter expertise in cell-culture process development for biologics, fed-batch cell culture, bioreactor scale-up and scale-down, as well as recent advances, and challenges in the field.
• Experience with intensified fed-batch and/or perfusion process development and associated process-analytical technologies is preferred.
• Experience with cell line development a plus
• Excellent communication skills to exchange complex technical/scientific information with others in complex situations
• Ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team
• Resilient and able to work well in a demanding, fast paced entrepreneurial environment.

Education and Experience:

• Bachelor's degree in a relevant field is required
• Typically requires a Bachelor's degree and 8+ years of experience or a Master's degree and 5+ years of experience or a PhD and 2-5 years of experience, or the equivalent combination of education and experience

Pay Range:

Disclosure Statement:

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