Senior Specialist, MSAT Validation & LCM

Bristol-Myers Squibb Co; Leiden; Hybrid; EUR 90,000 - 110,000; Full time

Job summary

Bristol Myers Squibb Netherlands is seeking a Senior Specialist, MSAT Validation & LCM to provide validation and lifecycle support at the Leiden Cell Therapy Facility. You will participate in facility, process and aseptic validation activities, work on tech transfers, and support lifecycle changes with cross-functional teams.

Role requires strong cGMP knowledge, 5+ years in biopharma operations, and experience with audits. Hybrid work model and global regulatory readiness are core priorities.

Qualifications

• Bachelor’s degree in science, engineering, biochemistry or related discipline; advanced degree preferred.
• Minimum of 5 years’ experience in biopharmaceutical operations or equivalent.
• Experience with internal and health authority audits, particularly pre-licensure inspections.

Responsibilities

• Supports validation activities for new products or processes at the Leiden CTF.
• Responsible for CTF Process Validation activities including APS/APV and PPQ.
• Performs data analysis and prepares protocols, reports and summaries for validation.
• Designs and executes test plans and risk mitigation activities for investigations.
• Interfaces with process engineers and serves as process validation SME.
• Leads site Change Controls and supports lifecycle management changes.

Skills

cGMP knowledge

Process validation

Data analysis

Communication skills

Biopharmaceuticals

Education

Bachelor’s degree in science, engineering, biochemistry or related discipline

Advanced degree preferred

Tools

APS/APV

PPQ

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 Senior Specialist, MSAT Validation & LCM provides process validation and Lifecycle Management support to the Leiden Cell Therapy Facility (CTF). The Senior Specialist participates in facility, process, and aseptic validation activities, including process tech transfers, and supports the implementation of product lifecycle changes at the site.

Key Responsibilities

• Supports validation activities for new products or processes related to the facility.
• Responsible for CTF Process Validation activities including, but not limited to, Aseptic Process Simulations/ Validations (APS/APV) and Process Performance Qualifications (PPQ).
• Performs data analysis, including the use of statistics, and prepares written protocols/reports/summaries supporting validation studies and life cycle management.
• Design and execute test plans and other risk mitigation exercises as part of investigations (e.g., Root cause analysis and CAPAs) related to validation studies.
• Interface with process engineers and serve as process validation SME.
• Supports site implementation of Lifecycle Management changes
• Supports equipment and facility commissioning, qualification and validation.
• Leads/Owns site Change Controls
• Participates in facility and process risk assessments and authors qualification/ validation documents (e.g. procedures, protocols and reports) in accordance with internal and external regulatory expectations.
• Supports investigations and global change controls as required.
• Ensures safe and compliant cGMP operations, maintains permanent inspection readiness, and actively supports regulatory inspections.
• Supports continuous improvements that reduce safety risks, operational costs, lead times, scrap, and discrepancy rates across all aspects of production.
• Serves as a MSAT representative on cross-functional and multi-site teams
• Maintains effective collaborative relationships across the site and network Foster strong inter-team relationships to achieve common project goals.
• Support MSAT management in accomplishing productivity and financial goals with the cross-functional team.
• Participate in routine plant operating meetings

Qualifications and Experience

Specific Knowledge, Skills, Abilities

Proficient in cGMP’s and multi-national biopharmaceutical/cell therapy regulations Experience in facility/clean room design, process, equipment, automation, and validation. Experience in assessing and implementing product lifecycle changes Experience with internal and health authority audits, particularly pre-licensure inspections (PLIs) Excellent verbal/written communication skills and ability to influence at all levels

Education/Experience/ Licenses/Certifications

Knowledge of science generally attained through studies resulting in a Bachelor’s degree in science, engineering, biochemistry or related discipline, or its equivalent is required. Advanced degree preferred. A minimum of 5 years’ experience in biopharmaceutical operations or its equivalent is required #LI-Hybrid

We hire for skills and capabilities, not just credentials – if this role excites you, but