Manager, MSAT Validation & LCM

Bristol-Myers Squibb Co; Leiden; Híbrido; EUR 110.000 - 140.000; Jornada completa

Descripción de la vacante

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, process validation, data analysis, and lifecycle management tasks essential to product supply.

Responsibilities include coordinating process engineers, managing change controls, and ensuring regulatory readiness, cGMP compliance, and continuous improvement across manufacturing operations.

Formación

• Proficient in cGMPs and biopharmaceutical/cell therapy regulations.
• Experience with facility/clean room design, validation and lifecycle changes.
• Excellent written and verbal communication; ability to influence at all levels.
• Experience with audits, including pre-licensure inspections (PLIs).

Responsabilidades

• Lead validation activities for new products/processes at Leiden CTF.
• Oversee Aseptic Process Simulations/PPQ and lifecycle validation tasks.
• Prepare protocols, reports and summaries supporting validation studies.
• Coordinate with process engineers; serve as validation SME.
• Own site change controls and risk assessments; develop qualification documents.

Conocimientos

cGMP knowledge

Validation leadership

Communication skills

Regulatory interaction

Educación

Bachelor's degree in science/engineering

Advanced degree preferred

Descripción del empleo

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 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

• 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.

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We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.