Job Description
JOB TITLE: Process Dev Engineering Principal Scientific Associate
LOCATION: 50 Northern Avenue, Boston, Massachusetts 02210
OPENINGS: 1
DUTIES:
Support the development of robust, scaled upstream or downstream production processes and methods for cell and gene therapy projects.
Perform stem cell expansion and differentiation in bench-scale bioreactors to support media development and optimization using high-throughput bench scale systems (Ambr15/Ambr250).
Development and documentation of protocols and technologies in support of upstream and downstream cell product development from clinical to commercial scale.
Apply DoE/QbD principles in process development and characterization, establishing process parameters, and contributing to CMC sections of regulatory filings.
Transfer processes to internal manufacturing and CDMOs, providing documentation, training, and technical support to ensure successful scale-up and implementation in cGMP environments.
Plan, execute, and document experiments and data analyses in support of process improvement.
Draft study protocols and reports while ensuring data integrity.
Contribute to technical reports, regulatory filings, source documents, patents, and external publications.
Prepare data analysis and deliver technical presentations to both the internal and external stakeholders in the process development department.
Utilize industry standard quality management tools (RCA, FMEA) to troubleshoot and continuously improve process issues.
Collaborate with cross-functional teams to meet project deliverables by providing technical expertise from lab experiment results to enable data-driven decisions for key stakeholders.
REQUIREMENTS: Employer will accept a Master’s degree in Biotechnology, Science, Engineering or a related field and 3 years of experience in the job offered or in Process Dev Engineering Principal Scientific Associate-related occupation.
Alternatively, employer will accept a Bachelor’s degree in Biotechnology, Science, Engineering or a related field and 5 years of experience in the job offered or in a Process Dev Engineering Principal Scientific Associate-related occupation.
Position requires demonstrable experience in the following:
- Experience in process development, optimization and characterization using DoE/QbD approaches for cell therapy products in ongoing and future projects.
- Exceptional aseptic techniques and hands-on cell culture laboratory experience with stem cells and mammalian cells in bench or bioreactor systems.
- Experience with small-scale bioreactors with working knowledge of scale-up parameters and strategies.
- Hands-on experience with routine and product-specific cell culture assays, including cell counting, metabolite analysis, flow cytometry, morphology, ddPCR, nucleic acid and protein assays, stem cell isolations, electroporation and cell harvest methods.
- Experience in potency and efficacy assay development and execution to evaluate the product quality profile of cell therapy products.
- Experience with data analysis and statistical software including GraphPad Prism, JMP, and Excel to support process optimization and cell culture studies
- Documentation and technical report writing to support research deliverables, regulatory filings and commercial milestones.
- Knowledge of cell therapy product profiles, including iPSC-derived cell therapy products, hematopoietic stem cells and other mammalian cells.
- Deep understanding of 2D/3D stem cell culture expansion and differentiation in high throughput cell culture systems.
- Experience transferring processes to internal manufacturing or CDMOs, including preparation of technical documentation, training, and technical support for cGMP implementation.
- Utilization of industry-standard quality management tools (RCA-FMEA) to troubleshoot process deviations and continuously improve the process.
- Strong molecular biology expertise with CRISPR/Cas9 genome editing technologies, including assay development to evaluate editing efficiency and therapeutic performance.
Rate of Pay: $106870.00 - $110900.00
CONTACT: Send Resume to futuretalent@vrtx.com. Reference 12140.653. EOE.
Pay Range:
$86,800 - $130,200Disclosure 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 DesignatedFlex 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.
#LI-Onsite
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]
Skills Required
- Master's degree in Biotechnology, Science, Engineering or related field and 3 years of relevant experience OR Bachelor's degree in Biotechnology, Science, Engineering or related field and 5 years of relevant experience
- Experience in process development, optimization and characterization using DoE/QbD for cell therapy products
- Exceptional aseptic techniques and hands-on cell culture experience with stem cells and mammalian cells in bench or bioreactor systems
- Experience with small-scale bioreactors (e.g., Ambr systems) and knowledge of scale-up parameters and strategies
- Hands-on experience with routine and product-specific cell culture assays (cell counting, metabolite analysis, flow cytometry, morphology, ddPCR, nucleic acid and protein assays)
- Experience with stem cell isolations, electroporation, cell harvest methods, and 2D/3D stem cell expansion and differentiation in high-throughput systems
- Experience in potency and efficacy assay development and execution to evaluate product quality
- Experience transferring processes to internal manufacturing or CDMOs, including preparing technical documentation, training, and cGMP implementation support
- Proficiency with data analysis and statistical software including GraphPad Prism, JMP, and Excel
- Documentation and technical report writing to support research deliverables, regulatory filings, and commercial milestones
- Utilization of industry-standard quality management tools (RCA, FMEA) to troubleshoot process deviations and drive continuous improvement
- Strong molecular biology expertise with CRISPR/Cas9 genome editing, including assay development to evaluate editing efficiency and therapeutic performance
- Knowledge of cell therapy product profiles including iPSC-derived products and hematopoietic stem cells
Vertex Pharmaceuticals Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Vertex Pharmaceuticals and has not been reviewed or approved by Vertex Pharmaceuticals.
-
Parental & Family Support — Policies provide 12 weeks of 100% paid bonding leave for all U.S. parents with additional fully paid time for birth parents. Family-forming supports include adoption and surrogacy assistance, fertility options like IVF and egg cryopreservation, breast‑milk shipping, subsidized childcare, backup care, and a DCFSA match.
-
Leave & Time Off Breadth — Time off includes roughly four weeks of vacation, 13 holidays, sick time, and two companywide shutdowns (summer and year‑end). Some roles also include flexible or unlimited time off and paid volunteer time.
-
Retirement Support — Programs include a 401(k) plan with employer contributions and an employee stock purchase plan. Filings describe employer contributions occurring in company stock, supporting long‑term ownership.
Vertex Pharmaceuticals Insights
What We Do
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston’s Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 3,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards.
