Job Description

General Summary:

Vertex is seeking a talented individual to join our Process Development team as a Senior Scientist/Manager. The Process Development Engineering Senior Scientist/Manager will be responsible for leading projects in process development and optimization, as well as leading characterization of cell products for ongoing and future projects. This role entails working on large scale bioreactors (≥50L) and will focus on developing scalable processes that drive projects forward to support our Type 1 Diabetes program.

Key Duties and Responsibilities:

• Design and execute experimentation to develop robust manufacturing processes for cell therapy products and implementation to support programs in clinical development.
• Develops robust, scalable bioreactor processes for cell therapy
• Evaluates novel and emerging technologies to advance project strategy
• Supports parts of technology transfer to CDMO and provide oversight for large-scale production
• Applies QbD principals to process characterization, establishes process parameters, and contributes to CMC sections of regulatory filings
• Leads projects within own team and provides training/support to other scientists/engineers on large scale bioprocessing.
• Deep understanding principles, methodologies and concepts related to cell culture and bioreactor scale up operations.
• Applies fundamental scientific and engineering principles to process design, development, and process understanding.
• Ability to apply statistical principles to guide process optimization
• Develops strategy for process development and optimization at 50L scale and beyond.
• Drives development activities working in a cross-functional environment
• Authors and reviews batch records, technical reports and relevant supporting documents.
• Troubleshoots and resolves process challenges through the application of acquired technical experience.

Knowledge and Skills:

• Must have large-scale bioprocessing experience and exposure to running 50-200L bioreactors.
• Prior knowledge of cGMP and GLP environments is required.
• Experience in design of experiments (DOE) and statistical analysis.
• Excellent communication skills to exchange complex technical/scientific information with others in complex situations.
• Excellent verbal and written communication skills and ability to handle multiple tasks while meeting timelines and adapting to changing priorities.

Education and Experience:

Bachelor's degree in Chemical Engineering, Bioengineering, Biochemistry, Biology or relevant field is required and 8+ years of experience or a Master's degree and 5+ years of experience or a PhD and 2-5 years of experience.

#LI-onsite #LI-SV1

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