Principal Scientist, Sterility Assurance
Bristol Myers Squibb
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.
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
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 Principal Scientist Sterility is an individual contributor responsible for quality oversight of the site contamination control strategy, including Environmental
Monitoring (EM).
NOTE: this role requires shift work and initial contract is fixed term 12 months.
Key Responsibilities:
• Quality oversight and support for contamination control programs such as
environmental monitoring, cleaning and disinfection, gowning, access
and flow, facility modifications, qualifications, disruptions, and shutdowns.
• Quality oversight and support for Microbiology QC Testing Methods.
Review and approve associated document revisions, protocols, reports,
testing plans.
• Review and approve investigations/ CAPAs / effectiveness checks
associated with the manufacturing site including but not limited to
environmental monitoring excursions, aseptic personnel qualification
(APQ), aseptic operations, cleanrooms, utilities, and Microbiology
laboratory.
• Quality Oversight and Management of Environmental Monitoring
Trending Program. Author or Review and approve EM and Utility trending
reports at designated frequencies (i.e., quarterly, and annually).
• Review and approve qualification lifecycle documentation associated with
manufacturing cleanrooms, water and gas utilities, including but not
limited to environmental monitoring process qualification (EMPQ), aseptic
process simulation (APS), airflow visualization (AVS), cleanroom
reclassification (CRC).
• Creation and Revision of technical documents (SOPs, Risk Assessments,
Reports, Protocols, etc.). Quality Approvals of documents created by
others.
• Quality oversight and approvals for disruptions and shutdowns to the
cleanroom environment.
• Facilitate and/or approve quality risk assessments and technical reports
associated with the contamination control strategy (CCS), including but
not limited to disinfectant efficacy testing, product process and facility
microbial risk assessments.
• Review and approve or provide impact assessments for site change
controls. Author impact assessments for complex level site change
controls and EMPQ assessments.
• Support the Contamination Control Strategy, Quality Initiatives, and
Identify continuous improvement opportunities. Support execution of
site/team improvement goals and projects related to environmental and
contamination control programs. Perform associated quality approvals as
required.
• Routinely recognize and resolve Quality issues; propose solutions for
complex issues and work with management to resolve.
• Support internal and external inspections as required. Participate in the
preparation and execution of corrective and preventative actions related
to inspection findings. Perform associated quality approvals as required.
• Maintain compliance with assigned learning plan. Support development
of training content.
• Act as Subject Matter Expert and provide guidance/ coaching to other
functions with atypical microbial events.
• Lead meetings and represent function at cross functional and network
meetings. Share data/ knowledge within team, and across site and
network.
• Ability to collaborate with cross-functional team members on projects
related to contamination control program. Build and maintain strong
relationships with partner departments.
• Perform other tasks as assigned.
Specific Knowledge, Skills, Abilities:
• Experience in FDA/EMA regulations in biopharmaceuticals or cell
therapy manufacturing.
• Demonstrated ability to collaborate cross-functionally to develop and
maintain strong business partner relationships.
• Demonstrated experience with electronic systems and databases.
• Demonstrated experience with root cause analysis and risk
management tools such as 5-WHY, Human Error Prevention, Fishbone
Analysis, FMEA, PrHA, etc.
• Demonstrated experience with electronic document and validation
documentation systems.
Education/Experience:
• Bachelor’s degree in Microbiology, Biology, STEM, or related science.
• 6+ years of relevant cGMP experience or equivalent combination of
education and experience in a regulated industry, preferably with 2+
years of Contamination Control and Quality assurance experience.
• Experience in Quality Control or Quality Assurance function in a cGMP
manufacturing operation. Experience with Aseptic Processes and
Practices, Contamination Control, Risk Management, and Quality
Systems.
#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
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
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. Visit 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: https://careers.bms.com/california-residents/
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 https://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.
