Manager, MSAT Validation & LCM

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: [](https://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](https://www.youtube.com/watch?v=hj8_j_FNzSU&t=19s) 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 [](https://www.bms.com/nl) or [](https://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 *If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.* **Uniquely Interesting Work, Life-changing Careers** With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. **On-site Protocol** BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. **Supporting People with Disabilities** BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [adastaffingsupport@bms.com](mailto:adastaffingsupport@bms.com). Visit [](https://careers.bms.com/eeo-accessibility)[eeo](https://careers.bms.com/eeo-accessibility)[-accessibility](https://careers.bms.com/eeo-accessibility) to access our complete Equal Employment Opportunity statement. **Candidate Rights** BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. 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: **Data Protection** We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at [](http://careers.bms.com/fraud-protection). Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [TAEnablement@bms.com](mailto:TAEnablement@bms.com). Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1605418 : Manager, MSAT Validation & LCM