Process Development Engineering Scientist

Job Description

General Summary:

Vertex is seeking a Scientist to join our Process Development group. This group offers a dynamic, fast-paced, and highly collaborative environment to make an impact. Our team focuses on bringing together the best process design, scale-up and cutting-edge manufacturing technologies to enable the successful implementation of cell and gene therapeutics.

The Process Development scientist is a bench-focused position responsible for the design and development of a robust scale-up process for cell therapy products. The scientist will collaborate closely with analytical development, technology transfer, manufacturing science and technology, internal manufacturing, CDMOs, and other internal and external partners to design and implement robust, scalable, and phase-appropriate manufacturing processes that enable clinical and commercial supply.

Key Responsibilities:

• Lead the design, execution, and analysis of experiments to develop robust, scalable manufacturing processes for cell therapy programs.

• Develop robust, scale-up process of bioreactor and cell processing for cell therapy.

• Drive optimization of cell culture processes including media screening, feed strategies, culture parameters optimization in stirred-tank bioreactor systems.

• Evaluate and implement emerging technologies to advance cell therapy products process development.

• Apply statistical tools and QbD principles to guide process optimization and characterization.

• Support technology transfer activities to internal and external manufacturing sites, including on-site technical support as needed.

• Author and review CMC sections of regulatory filings, as well as technical protocols, batch records, development reports, and standard operating procedures (SOPs).

Required Qualifications:

• Degree in Chemical Engineering, Biomedical Engineering, Biology or a related field. PhD with 0 to 3 years of industry experience; Master’s degree with 5+ years of industry experience or Bachelor’s degree with 6+ years of industry experience

• Hands-on experience in stirred tank bioreactor operation and scale-up development in fed-batch and/or perfusion mode. Or hands-on experience in cell processing systems operation and scale-up development. (Prior experience in stem cell or stem cell derived products cell culture and/or cell processing is highly desirable.

• Demonstrated proficiency in statistical tools (e.g. JMP) and their application to experimental design, process optimization and process characterization

• Highly self-motivated, proactive, and adaptable, with a passion for scientific problem-solving

• Excellent communication, collaboration, and time management skills

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 [email protected]