Process Development Engineering Principal Associate

Vertex Pharmaceuticals Inc (US); Leiden; On-site; EUR 75,000 - 113,000; Full time

Job summary

Vertex Pharmaceuticals Inc (US) seeks an MSAT Principal Associate to lead Manufacturing Science and Technology activities for cell therapy products. You will support technology development and transfer from Development to Clinical Manufacturing, drive continuous improvement, and oversee CDMO collaborations across life-cycle stages.

The role requires a PhD or Master’s with industry experience, strong risk management, and a track record in early/late-phase cell therapy programs.

Qualifications

• PhD in Life Sciences, chemical engineering, or related discipline (or Master’s with 2+ years) or Bachelor’s with 4+ years industry experience.
• Hands-on MSAT investigation and change management experience.
• Experience with cell therapy and/or gene therapy programs preferred.

Responsibilities

• Lead triage, investigation, and change control as MSAT assessor.
• Manage delivery milestones, timelines, and risk communications.
• Contribute to IND/IMPD regulatory submissions and create supporting docs (reports).
• Oversee CDMOs and ensure performance, quality, and on-time delivery.
• Drive lifecycle improvement, process development, and process excellence.

Skills

MSAT

Cross-functional teamwork

Cell processing experience

FMEA risk management

Communication skills

Regulatory submissions

Education

PhD in Life Sciences/Engineering

Master’s with 2+ years industry

Bachelor’s with 4+ years industry

Job description

Job Description General Summary

The Process Development Engineering Principal Associate responsible for Manufacturing Science and Technology (MSAT) activities for cell therapy products. The candidate will provide cross-functional support in technology development and transfer from Development to Clinical Manufacturing and Process Performance Qualification including internal operations and potentially various CDMOs. They are also responsible for planning and implementing continuous improvement initiatives for life-cycle management working in cross-functional environment.

Key Duties and Responsibilities

Lead triage, investigation, and change control implementation as a Manufacturing Science and Technology functional area assessor and identify improvements, implement changes, and monitor clinical and commercial manufacturing processes. Manage the execution of deliverables, both short and long-term, via clearly defined milestones, and timelines. Minimize timeline deviations by clearly identifying program risks and communication of strategies Contribute to regulatory submissions (IND, IMPD). Author supporting documents and reports. Coordinate and integrate cross-functional activities to ensure alignment in scope, schedule and budget Drive continuous improvement activities and operational excellence, including COGS reduction and commercial readiness. Support pre-PPQ and PPQ activities. Establish robust process performance across all clinical and commercial manufacturing lines, including process development, process improvement, and maintenance of process excellence. Lead process monitoring, continuous improvement, and lifecycle management initiatives guided by risk assessment and mitigation strategies Oversee CDMOs activities by providing guidance and support in collaborative manner. Be responsible for the performance, quality and delivery of external collaborators Collaborate within departmental teams, actively contribute to deliverables and engage in team discussion on issue resolution.

Knowledge and Skills

Excellent communication skills to exchange technical/scientific information to a wide variety of audiences Ability to build collaborative relationships and work effectively as a member of a multidisciplinary team Experience working with cell processing, specifically with primary cells. Experience with cell therapy products is preferred Knowledge of Design Control and Risk Management, including experience using FMEA analyses. Direct industry experience developing early and/or late phase clinical/commercial cell or gene therapies Excellent organizational skills and high attention to detail

Education and Experience

PhD in Life Sciences, chemical engineering, or related discipline or master’s degree with minimum 2+ years of industry experience or bachelor’s degree with 4+ years of relevant industry experience. Hands on experience with Manufacturing Science and Technology (MSAT) investigation and change management. Experience with cell-gene therapy is preferred.

Pay Range

$86,800 - $130,200 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 [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 16 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

Our Culture

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.