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:

$105,600 - $158,400

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

On-Site Designated

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

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 ...