Manager, MSAT Investigations

Biopharma Careers; Leiden; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Bristol Myers Squibb Netherlands is seeking a Manager, Investigations, Cell Therapy to provide leadership for complex root cause investigations at the Leiden Cell Therapy Manufacturing Facility. You will identify corrective actions, facilitate impact assessments, ensure audit readiness, and support regulatory inspections.

The role requires strong knowledge of cGMPs, cell therapy, and biologics manufacturing, with a focus on continuous improvement and risk-based decision-making.

Qualifications

• Root cause analysis experience with corrective and preventive actions.
• Familiar with cGMPs and multinational biopharmaceutical regulations.
• Bachelor’s degree in science, engineering, biochemistry or related discipline with at least 5 years in biopharmaceutical operations.

Responsibilities

• Lead complex root cause investigations and CAPAs.
• Collaborate with Process Engineering, Engineering & Facilities, Manufacturing Operations, QA and QC.
• Drive timely and compliant closure of investigations per KPIs.
• Present investigation findings to site senior management.
• Apply Quality Risk Management and Operational Excellence principles to improve processes.
• Support regulatory inspections and maintain audit readiness.
• Coach colleagues on Investigation Program fundamentals.

Skills

Root cause analysis

Operational Excellence

Cell therapy background

cGMP compliance

Communication and influence

Strategic thinking

Team guidance

Product complaints/APQRs

Education

Bachelor’s degree in science/engineering/biochemistry

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.

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, Investigations, Cell Therapy provides investigation leadership and support to the Leiden Cell Therapy Manufacturing Facility. The Manager will perform complex root cause analysis, work with stakeholders to identify corrective and preventative actions, facilitate impact assessments, ensure the Manufacturing Science & Technology team is audit ready, facilitate Annual Product Quality Reviews, and investigate product complaints.

Key Responsibilities

• Conducting and managing the resolution of complex/multi-functional root cause investigations, including impact assessments, CAPAs, and product complaints as a Lead Investigator
• Collaborating with many different groups/organizations as a Lead Investigator including Process Engineering and Support, Engineering and Facilities, Manufacturing Operations, Quality Assurance, and Quality Control
• Proactively managing the progression of investigations and CAPAs to timely and compliant closure per established KPIs
• Presentation of investigation findings to key stakeholders and site senior management
• Use of Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste
• Ensuring safe and compliant cGMP operations and maintaining permanent inspection readiness; Actively supporting regulatory inspections
• Staying current with industry trends and BMS standards and participating in best practice forums consistent with function responsibilities.
• Coaching and mentoring of colleagues on Investigation Program fundamentals and best practice

Experience, Skills, and Abilities

• Experience utilizing root cause analysis tools and identifying corrective and preventative actions is required
• Experience with Operational Excellence and Lean Manufacturing is a plus
• Experience in cell therapy, biologics, or vaccine manufacturing/support desired
• Proficient in cGMP’s and multi-national biopharmaceutical/cell therapy regulations
• Excellent verbal/written communication skills and ability to influence at all levels
• Ability to think strategically, and to translate strategy into action
• Ability to prioritize and provide clear direction to team members in a highly dynamic environment
• Experience in product complaints and/or APQRs is a plus

Education and Knowledge

Knowledge of science generally attained through studies resulting in a Bachelor’s degree in science, engineering, biochemistry or related discipline plus a minimum of 5 years’ experience in biopharmaceutical operations, or its equivalent is required

Working Conditions

Position may require working in Clean-Room manufacturing environment approximately 15% of the time. Remainder of work is performed in an office environment.

#LI-Hybrid

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 workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in 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.