Senior Specialist, MSAT Investigations

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

Benefits offered by this job

Hybrid work model

Job summary

Bristol Myers Squibb, Leiden Cell Therapy Facility, is seeking a Senior Specialist, Investigations, Cell Therapy to lead root-cause investigations, assess corrective actions, and drive CAPAs in a multi-group setting. You’ll collaborate across Process Eng, Facilities, Manufacturing Ops, QA, and QC to ensure timely, compliant investigations and risk-based decisions.

The role emphasizes cGMP operations, regulatory readiness, and continuous improvement, with hybrid work options and a focus on cell

Qualifications

• Bachelor’s degree in science, engineering, biochemistry or related discipline with 2–4 years biopharmaceutical operations experience.
• Experience with root cause analysis and corrective actions.
• Experience in cGMP and multinational biopharma regulations is preferred.

Responsibilities

• Conducting and managing the resolution of root cause investigations, including impact assessments, and CAPAs 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

Skills

Root cause analysis

CAPA

Quality Assurance

Quality Control

Operational Excellence

Lean Manufacturing

Cell therapy

Biopharmaceutical operations

cGMPs

Regulatory inspections

Communication skills

Strategic thinking

Education

Bachelor's degree in science/engineering/biochemistry or related discipline

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 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 Senior Specialist, Investigations, Cell Therapy provides investigation leadership to the Leiden Cell Therapy Facility. The Senior Specialist will perform root cause analysis, work with stakeholders to identify corrective and preventative actions, and facilitate impact assessments.

Key Responsibilities

• Conducting and managing the resolution of root cause investigations, including impact assessments, and CAPAs 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

Experience, Skills, and Abilities

• Experience utilizing root cause analysis/OPEX tools and identifying corrective and preventative actions preferred
• Experience with Operational Excellence and Lean Manufacturing is a plus
• Experience in cell therapy, biologics, or vaccine manufacturing/support desired
• Experience in cGMP’s and multi-national biopharmaceutical/cell therapy regulations desired
• 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

Education and Knowledge

Knowledge of science generally attained through studies resulting in a bachelor’s degree in science, engineering, biochemistry or related discipline plus 2-4 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 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.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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.