Process Development Engineering Senior Scientist

Vertex Pharmaceuticals Inc (US); United States; On-site; USD 123,000 - 185,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Paid time off

Job summary

Vertex is seeking a Senior Scientist to lead process development for a cell-based drug candidate targeting diabetes. The role focuses on robust process development, characterization studies, and may support manufacturing investigations.

Weekend shift leadership ensures continuous coverage for ongoing studies and tight timelines. The ideal candidate will be experienced in cell culture processes for biologics or cell therapy, with DOE and statistical analysis expertise, and a strong GMP

Qualifications

• BS in Biochemistry, Engineering, Biology or related discipline with 8+ years of industry experience.
• MS with 5+ years of industry experience.
• PhD with 2-5 years of industry experience.

Responsibilities

• Design and execute experiments to develop robust manufacturing processes for cell therapy products.
• Lead process robustness and characterization studies.
• Coordinate weekend shift team to ensure continuity of ongoing studies.
• Communicate progress and develop weekend coverage plans.
• Manage pluripotent stem cell culture and differentiation for development and characterization.
• Document procedures and results per guidelines.
• Perform statistical analysis to identify critical parameter ranges.
• Collaborate cross-functionally to drive development activities.

Skills

Weekend shift leadership

Process development

DOE / statistics

Cell culture

GMP knowledge

Communication

Project leadership

Education

BS in Biochemistry, Engineering, Biology or related discipline

MS with 5+ years of industry experience

PhD with 2-5 years of industry experience

Tools

Stirred tank reactors

ATFs

Ambr250

Unifuge Mini

Job description

Job Description General Summary

Vertex is seeking a talented individual to join our Process Development team as a Senior Scientist. The primary focus of this role is to lead the execution of process development and engineering studies for a cell-based drug candidate designed to treat diabetes. The Senior Scientist will be responsible for internal process development work, including process robustness and characterization studies, and may support manufacturing investigations. Importantly, the Senior Scientist will lead a weekend shift team to provide continuity for on-going studies over weekends and holidays.

Shift Information

This is a full-time weekend Thursday to Monday 8am to 5pm. The Process Development group offers a fast-paced and high energy environment. The right candidate will be a subject matter expert in process engineering, or similar relevant field(s) and have a solid technical operations background.

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.
• Lead process robustness and characterization studies to support process understanding and clinical development goals.
• Lead and train the weekend shift team of bioprocess associates and engineers who will work closely together within a highly matrixed, cross-functional team to deliver program goals.
• Communicate effectively to develop reliable weekend coverage plans for ongoing studies, including understanding experimental goals, developing schedules, and delegating the work to the weekend shift team.
• Manage and/or execute pluripotent stem cell culture and differentiation to support process development, optimization, and characterization.
• Manage troubleshooting with high degree of complexity.
• Document experimental procedures and results according to established guidelines.
• Perform statistical analysis of experimental data to determine critical process parameter ranges.
• Communicate progress versus plan, identifying and escalating business-critical issues affecting supply and timelines as necessary, providing recommendations, mitigations, and potential solutions.
• Collaborate effectively within departmental teams, contribute to deliverables and drive development activities in a cross-functional environment, engage on team discussions to resolve issues, and lead projects with a fully integrated team to facilitate successful outcomes.
• Coordinate resources and set priorities for own team, contributing to the overall goals of the department.
• Generate and review technical reports, regulatory filings, source documents, patents and external publications, as applicable.

Knowledge and Skills

• Enthusiastic about maintaining a weekend and holiday shift schedule.
• Willingness to effectively lead a team of scientists/engineers, minimum of 1 year of direct management experience.
• Strong communicator with experience collaborating on projects and managing changing priorities.
• Experience independently conducting and directing the design, execution, analysis, and documentation of cell culture processes for biologics and/or cell therapy products.
• Experience in design of experiments (DOE) and statistical analysis.
• Pluripotent stem cell culture experience in 2D and/or 3D preferred.
• Experience working with cell processing devices and bioreactors such as stirred tank reactors, Unifuge Mini, ATFs, and Ambr250.
• Working knowledge of GMP requirements.
• Excellent verbal and written communication skills and ability to handle multiple tasks while meeting timelines and adapting to changing priorities.
• Strong organizational skills and high attention to detail.

Education and Experience

• BS in Biochemistry, Engineering, Biology or related discipline with 8+ years of industry experience
• an MS with 5+ years of industry experience
• a PhD with 2-5 years of industry experience

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range

Pay Range: $123,200 - $184,800 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

Designation 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 [e-mail] Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 17 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.