Senior Manager Process Validation

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 rich in diversity. 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 firstEuropean 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 atbms.com/nlorcareers.bms.com/nl

Position Summary

The Senior Manager Process Validation is responsible for managing site process related validation activities and she/he reports to the AD validation. This function is responsible for management of Technology Transfer from outside and for the validation studies through the entire life cycle and of the CAR-T processes at Leiden site. Additionally, this role will acts as SME on validation studies (also at bench scale when needed), including APS, APQ and Process validation and presents these activities to the authorities during an audit.

He/She collaborates with SMEs from the Process Engineering, MES/Automation, Manufacturing, Quality Assurance and Quality Control to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.

Key Responsibilities

  • Maintain permanent inspection readiness and actively support regulatory inspections.
  • Foster a culture of compliance and strong environmental, health, and safety performance
  • Support the tracking of team metrics and manage completion of objectives and projects
  • Continuously monitor, analyze, and optimize the end-to-end process and anticipate and permanently resolve issues that may arise during the activities
  • Support related investigations, ensuring compliance with internal standards and regulatory requirements
  • Support change initiatives and the implementation of process improvement initiatives
  • Work closely with Process Engineering and Automation/MES team on the design, implementation and validation of new technologies related to the process and facility
  • Review and approve the content of technical documentation (e.g. investigations, changes, SOPs and batch records, protocols and reports)

Sponsor and Qualifications & Experience

  • Master’s degree in relevant science or engineering discipline
  • In depth Knowledge of process engineering or process validation required
  • Knowledge of Lean Manufacturing principles required.
  • Minimum of 7 years of experience in cGMP biologics manufacturing, preferably in cell therapy
  • 2+ years supervising staff in a management role

# LI-Onsite

Disclaimer: For any third parties or external agencies, please, be informed we do not accept unsolicited requests, proposals, applications or profiles for any of our roles at BMS.

Why You Should Apply

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 an inclusive culture, promoting diversity 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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