Senior Specialist, MSAT Validation & LCM

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

Job summary

Bristol-Myers Squibb in Leiden seeks a Senior Specialist, MSAT Validation & LCM to provide process validation and lifecycle management support at the Leiden Cell Therapy Facility (CTF). The role involves participation in facility and aseptic validation activities, including tech transfers, and supporting lifecycle changes at the site.

The candidate should have 5+ years in biopharmaceutical operations, strong cGMP knowledge, and experience with audits.

Qualifications

• Bachelor’s degree in science, engineering, biochemistry or related discipline.
• Minimum 5 years’ experience in biopharmaceutical operations.
• Experience with audits by health authorities (PLIs) is a plus.

Responsibilities

• Supports validation activities for new products or processes at the Leiden facility.
• Leads/Owns site Change Controls.
• Executes test plans and risk mitigation for validation studies.
• Interfaces with process engineers as validation SME.
• Ensures cGMP compliance and inspection readiness.

Skills

cGMP compliance

Process validation

Lifecycle management

Aseptic processing

Communication skills

Education

Bachelor’s degree in science/engineering/biochemistry or related

Advanced degree preferred

Job description

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

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

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