Manager, MSAT Validation & LCM

Bristol-Myers Squibb; Netherlands; On-site; EUR 90,000 - 120,000; Full time

Job summary

Bristol Myers Squibb Netherlands is seeking a Manager, MSAT Validation &LCM to provide process validation and lifecycle management support to the Leiden Cell Therapy Facility (CTF). The role leads validation activities for facility, processes and aseptic operations, including tech transfers.

The ideal candidate will bring deep cGMP knowledge, experience in validation and lifecycle changes, and a proven ability to work with audits and cross-functional teams to ensure compliance and continuous

Qualifications

• Proficient in cGMPs 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 PLIs.
• Excellent verbal/written communication skills and ability to influence at all levels.

Responsibilities

• Lead validation activities for new products or processes related to the facility.
• Responsible for CTF Process Validation activities including APS/APV and PPQ.
• Performs data analysis, including statistics, and prepares protocols/reports/summaries.
• Design and execute test plans and other risk mitigation exercises as part of investigations.
• Interface with process engineers and serve 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/Lead facility and process risk assessments and author qualification/validation documents.
• Support investigations and global change controls as required.
• Ensure safe and compliant cGMP operations and inspection readiness as SME.
• Identify and drive continuous improvements to reduce risks, costs, lead times.
• Serve as MSAT representative on cross-functional and multi-site teams.
• Build and maintain strong inter-team relationships to achieve goals.
• Support MSAT management in productivity and financial goals with the cross-functional team.
• Participate in routine plant operating meetings.

Skills

cGMP knowledge

Regulatory experience

Facility/clean room design

Process validation

Lifecycle management

Audits & inspections

Communication skills

Education

Bachelor's degree in science or engineering

Job description

Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

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 MSAT 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

• 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, engi