Process Development Engineering Senior Scientist

Vertex Pharmaceuticals Incorporated; Boston (MA); On-site; USD 123,000 - 185,000; Full time

Job summary

Vertex is seeking a Senior Scientist to lead process development and engineering studies for a cell-based drug candidate. Based in Boston, MA, you will manage weekend shift bioprocess teams and drive robustness and characterization studies across clinical programs.

You will design experiments, supervise pluripotent stem cell culture, perform DOE and statistics, and collaborate in a matrixed team to deliver program goals while ensuring GMP compliance and thorough documentation.

Qualifications

• Weekend shift leadership experience preferred.
• Minimum of 1 year direct management experience.
• Strong communicator with cross-functional collaboration experience.
• 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.
• Strong organizational skills and high attention to detail.

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.

Education

BS in Biochemistry, Engineering, Biology or related discipline

MS in Biochemistry, Engineering, Biology or related discipline

PhD in Biochemistry, Engineering, Biology or related discipline

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. This is a full-time weekend and holiday shift position based in our Boston, MA facilities.

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; or an MS with 5+ years of industry experience; or 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:

$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 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.

#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 [e-mail]