Manager, MSAT Validation & LCM

Bristol Myers Squibb; Leiden; Hybrid; EUR 90,000 - 140,000; Full time

Job summary

Bristol Myers Squibb Netherlands is seeking a Manager, MSAT Validation & LCM to lead validation activities at the Leiden Cell Therapy Facility. You will drive aseptic validation, PPQ, and lifecycle changes, interfacing with process engineers and ensuring compliance in a fast-paced biopharma environment.

You will guide investigations, risk assessments, and regulatory readiness while partnering with cross-functional teams to advance cell therapy programs and site improvements.

Qualifications

• Proficient in cGMPs and international biopharmaceutical regulations.
• Experience with facility/clean room design, process, equipment, automation, and validation.
• Experience in assessing and implementing lifecycle changes.
• Experience with internal and health authority audits, especially PLIs.
• Excellent verbal and written communication and influencing skills.

Responsibilities

• Lead validation activities for new products or processes at the Leiden Cell Therapy Facility.
• Own CTF process validation activities including APS/APV and PPQ.
• Perform data analysis with statistics; prepare protocols, reports, and summaries.
• Design and execute test plans and risk mitigations for investigations.
• Interface with process engineers and act as process validation SME.
• Lead site implementation of lifecycle management changes.
• Support equipment and facility commissioning, qualification and validation.
• Lead/own site Change Controls.
• Participate in facility and process risk assessments and author qualification/validation documents.
• Support investigations and global change controls as required.
• Ensure safe, compliant cGMP operations and inspection readiness; support regulatory inspections.
• Identify and drive improvements reducing risks, costs, lead times, scrap, and discrepancies.
• Serve as MS&T representative on cross-functional and multi-site teams.
• Build relationships across site and network to support lifecycle programs.
• Foster inter-team collaboration to achieve goals.
• Support MSAT management in productivity and financial targets with cross-functional teams.
• Participate in routine plant operating meetings.

Skills

cGMP regulatory knowledge

Facility/clean room design

Process validation

Audits & PLIs experience

Communication & influence

Education

Bachelor’s degree in science/engineering/biochemistry

Advanced degree preferred

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, MS&T Validation & LCM provides process validation and Lifecycle Management support to the Leiden Cell Therapy Facility (CTF). The Manager leads and participates in facility, process, and aseptic validation activities, including process tech transfers.

Key Responsibilities

• Lead 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 exercise 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.
• Leads site implementation of Lifecycle Management changes
• Supports equipment and facility commissioning, qualification and validation.
• Leads/Owns site Change Controls
• Participates in/Leads 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 as a Subject Matter Expert.
• Identifies, prioritizes and drives continuous improvements that reduce safety risks, operational costs, lead times, scrap, and discrepancy rates across all aspects of production. Promotes problem identification and the creation of meaningful solutions through a culture of proactive problem prevention.
• Serves as a MS&T representative on cross-functional and multi-site teams
• Builds and maintains effective collaborative relationships across the site and network, influencing site and network product/process life cycle programs
• 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 8 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 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/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries [e-mail]. Visitcareers.bms.com/eeo-accessibilityto 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/

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If this posting is missing required information required by local law or incorrect, contact BMS [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.

R1605418 : Manager, MSAT Validation & LCM