Manager, MSAT Investigations

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!

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.

• 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 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

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.

Position may require working in Clean-Room manufacturing environment approximately 15% of the…