Manager, Process Engineer

Biopharma Careers; Leiden; On-site; EUR 90,000 - 140,000; Full time

Job summary

Bristol Myers Squibb Netherlands is seeking a Manager, Process Engineering to lead the technical side of CAR-T therapy production at the Leiden facility, ensuring continuous, compliant, and efficient 24/7 operations. This role collaborates with Process Validation, MES/Automation, Manufacturing, and Quality to drive rapid, flawless delivery of high-quality products.

The ideal candidate has 8+ years in cGMP biologics manufacturing, strong process engineering and Lean manufacturing knowledge, and a

Qualifications

• Deep knowledge of facility/clean room design, cell therapy processes, equipment and automation.
• Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies.
• Experience working with external parties and/or leading cross-functional teams.

Responsibilities

• Drive end-to-end process optimization and issue resolution on the production line.
• Lead investigations and CAPA activities for OOS, deviations and process changes.
• Ensure timely technical documentation reviews and approvals (SOPs, batch records, protocols).
• Provide on-site and on-call support for operations and shopfloor topics.
• Coordinate with MSAT, Manufacturing, Quality, and Supply Chain to ensure compliant, cost-effective delivery of therapies.
• Lead changes and continuous improvement initiatives across the multiproduct facility.

Skills

Cell therapy

Process engineering

cGMP knowledge

Automation

Leadership

Cross-functional collaboration

Analytical troubleshooting

Education

Bachelor’s degree in science or engineering

Advanced degree preferred

Tools

Lean Manufacturing

Job description

At Bristol Myers Squibb, our employees often ask, "Who are you working for?", a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Bristol Myers Squibb Netherlands

Bristol Myers Squibb has been active in the Dutch market for over 50 years, employing people across a range of activities and business units in Utrecht, The Netherlands.

The Netherlands is also home to our first European Cell Therapy facility, located at the Leiden Bio Science Park, the largest life sciences cluster of The Netherlands. This new state of the art facility is focused on commercial manufacturing with capabilities for multi-product Cell Therapy manufacturing. You can become part of this exciting journey. Check out this video if you want to know more about it!

The Netherlands has everything it takes to become the medicines hub of Europe, the so-called Boston by the North Sea. As we continue to expand our footprint by building this new site, we are looking to grow our team.

Would you like to become an important chain in our worldwide network to bring this new personalized treatment to patients suffering from blood cancer? Join us and be a game changer!

For more information about Bristol Myers Squibb Netherlands, visit us at bms.com/nl or careers.bms.com/nl

Position Summary

The Manager Process Engineering is responsible for implementing and supporting the production of CAR-T cell therapy products for both clinical trials and commercial supply as part of 24/7 operations at Leiden facility.

The Manager Process Engineering is responsible for managing activities in Process Engineering team from a technical perspective.

The Manager Process Engineering collaborates with SMEs from Process Validation, MES/Automation, Manufacturing, and Quality to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.

Duties/Responsibilities:

• Drive the processes to continuously monitor, analyze, and optimize the end-to-end process and anticipate and permanently resolve issues that may arise during production including Process Equipment System support and troubleshooting
• Provide technical input and guide lead investigators for process related investigations, including leading high criticality deviations ensuring compliance with internal standards and regulatory requirements.
• Drive and ensure technical documentation is reviewed and approved on time by MSAT PE department (e.g investigations, changes, SOPs, batch records, protocols and reports)
• Provides on-site and on-call support during operations and any process related topics coming from shopfloor and front-line support.
• Guide implementation of change initiatives and process improvement initiatives
• Interact with manufacturing, quality control, supply chain, facility & engineering, and quality assurance SMEs and leaders and serve as processes SME for the multiproduct facility.
• Interact with SMEs in the BMS Cell Therapy network.
• Drive internal collaboration with other MSAT functions for data collection, analysis, and interpretation of data and drive collaboration with cross-functional teams including Manufacturing, Quality Assurance and Supply Chain.
• Guide and provide input for preparations for regulatory inspections and support regulatory inspections. Ensure that all actions linked to MSAT process engineering are executed as per agreed timelines.
• Lead interactions with Engineering /Maintenance on the design and implementation of new technology and new systems/facilities related to production process needs.
• Coordinate and prioritize initiatives to ensure that risks from manufacturing operations that could negatively impact delivery of safe effective therapies to patients are identified and mitigated proactively. Accountable for ensuring the continuous optimization of the process.
• Manages project teams, coordinates the execution of technical projects and develops presentations to disseminate results to project stakeholders and senior management.
• Oversees campaign readiness activities with a cross-functional team to ensure flawless production campaigns.
• Ensure execution of test plans and other risk mitigation exercises as part of complex (major and critical) investigations (e.g. Root cause analysis and CAPAs for OOS or batch termination).
• Lead OOS investigations and act as Process Technical SME (including MRB)
• Foster strong inter-team relationships to achieve common project goals.
• Lead the tracking of team metrics and manage completion of objectives and projects
• Ensuring on time closure of Product/Process impact assessments, PQEs, CAPAs, and change controls. Perform process data monitoring.
• Create an environment of teamwork, open communication, and a sense of urgency, promoting flexibility, creativity, and accountability.
• Support organizational strategic goals and objectives that are linked to the overall company strategy
• Build trust and effective relationships with peers and stakeholders
• Foster a culture of compliance and strong environmental, health, and safety performance
• Support transition from technology transfer phase to commercial routine manufacturing, including Ramp and Training.

Qualifications:

• Deep knowledge of facility/clean room design, cell therapy processes, equipment and automation.
• Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies.
• Experience working with external parties and/or leading cross-functional teams.
• Possess strong verbal/written communication skills and ability to influence at all levels.
• Expert knowledge of cGMP’s and biopharmaceutical/cell therapy regulations.
• Capable of working well as a people manager and in a matrix environment, collaborating and guiding Process Engineering team and stakeholders.
• Ability to perform process and hands on troubleshooting, independent thinking and decision-making capability.
• Ability to think strategically and to translate strategy into actions.
• Experience in process change controls, complex deviations root cause analysis and impact assessment complying to quality systems requirements.
• Experience with Operational Excellence and Lean Manufacturing.

Education/Experience/Licenses/Certifications:

• Bachelor’s degree in relevant science or engineering discipline, or equivalent in work experience. Advanced degree preferred.
• Knowledge of Lean Manufacturing principles required.
• Minimum of 8 years of experience in cGMP biologics manufacturing, preferably in cell therapy in manufacturing or MSAT roles

Travel:

Occasional Travel may be required for this position.

Why You Should Apply

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustment prior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail] . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1604020 : Manager, Process Engineer