Senior Technical Lead II, Manufacturing, Cell Therapy

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profile Job Location:

Leiden - Netherlands

profile Monthly Salary: Not Disclosed
Posted on: 3 hours ago
Vacancies: 1 Vacancy

Job Summary

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: 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 or Summary
Our Senior Technical Lead II perform a crucial role in driving our novel cell therapy programs by supporting routine manufacturing operations. The Senior Technical Lead is responsible for oversight of all routine GMP cleaning operations and associated activities within the manufacturing areas. The Senior Technical Lead owns performance management and data analytics on (business) processes across multiple shift teams. We are searching for innovative intellectually curious individuals with a general understanding of Good Manufacturing Practices (GMPs) and performance management/ data analytics to support routine manufacturing operations
for Cell Therapy. Successful candidates must be goal-oriented collaborative and flexible with the ability to work effectively and efficiently on a team while demonstrating safety quality and GMP compliance at all times.

Duties/Responsibilities

Include but are not limited to the following:Manage the facility control strategy including contamination
control
APS (aseptic process simulation) scheduling and execution POC and manufacturing representative for environmental
monitoring review board
Owns all deviations generated associated with GMP cleaning Lead investigator (medium and complex investigations >
technical compliance and EHSS investigations).
Lead the matrix FLS (frontline support team) a cross departmental team (QA QC F&E IT MFG MSAT SC&L) to
solve deviations/breakdowns and guarantee continuation of operations
Proactively coordinated with external service providers to meet business needs and standards
Develops manages and reports on KPIs related to MFG operational execution including cleaning throughout the MFG
organization
Lead investigator (qualified) responsible for medium and high complex investigations across all manufacturing unit operations for technical compliance and EHSS investigations

Qualified trainer for all GMP operations closed and open operations including all grade B aseptic handling. The Official Copy is the electronic file. Verify document is the current version before proceeding.

Qualifications:

Preferred Experience:
Experience in cell therapy manufacturing including Cell washing processes and automated equipment. Cell separation techniques and automated equipment. Cryopreservation processes and equipment.

8 years of cGMP cell therapy manufacturing bioprocessing manufacturing or relevant experience and education
Extensive knowledge of cGMP regulations and FDA guidance applicable to cell therapy manufacturing
Experience in oversight third party activities
Peer-level on the floor leadership experience which demonstrates
proficiency and compliant schedule adherence is highly desired.
Demonstrated aptitude for engineering principles and
manufacturing systems.
Demonstrated proficiency in common computer tools such as word processing spreadsheet and web-based applications.

Working Conditions:
Must be able to stand/walk for extended periods of time

Must be able to work in a cleanroom environment and perform aseptic processing In ISO 5 biosafety cabinets which require gowning and personal protective equipment (PPE) including by not limited to: safety shoes safety glasses aprons face shields powered air purifying respirators (PAPR) lab coats full body
gowns hairnets gloves and hearing protection
Required to carry and/or lift up to 30 pounds / 15 kg several times a day while handling production equipment and/or materials
Required to push and/or pull up to 50 pounds / 15 kg several times a day while handling production equipment and/or materials
Work in areas that may have strong magnets

Must be able to work in a BSL2/ML1 work environment handling human blood components
Work in areas with exposure to vapor phase liquid nitrogen
Must be able to work assigned shift (Day Evening Night
Weekends and/or Holidays)

#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 doesnt 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 . Visit 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: Protection

We will never request payments financial information or social security numbers during our application or recruitment process. Learn more about protecting yourself at data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.


Required Experience:

Senior IC

Working with UsChallenging. Meaningful. Life-changing. Those arent 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 breakthrou...
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Key Skills

  • Lean Manufacturing
  • Six Sigma
  • Continuous Improvement
  • ISO 9001
  • Lean Six Sigma
  • Management Experience
  • Manufacturing & Controls
  • 5S
  • Manufacturing Management
  • Kaizen
  • Chemistry
  • Manufacturing

About Company

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Bristol-Myers Squibb is a global biopharmaceutical company focused on discovering, developing and delivering innovative medicines for patients with serious diseases. Our medicines are helping millions of patients around the world in disease areas such as oncology, cardiovascular, immu ... View more

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