Technical Lead Manufacturing, Cell Therapy
Bristol-Myers Squibb
- Location
- Leiden – NL
- Work model
- On-Site
- Level
- Senior
- H-1B history
- 57 approvals (FY2023)
- Posted
- 7h ago
About this role
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 . 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 Our Technical Lead perform a crucial role in driving our novel cell therapy programs by supporting routine manufacturing operations. We are searching for innovative, intellectually curious individuals with a general understanding of Good Manufacturing Practices (GMPs) to support routine manufacturing operations for Cell Therapy. Successful candidates must be goal-oriented 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 Execute operations described in Standard Operating Procedures (SOPs) and batch records Lead the matrix FLS (frontline support team) a cross departmental team (QA, QC, F&E, IT, MFG, MSAT, SC&L) Responsible for schedule adherence, cycle time and issue resolution. Report variances and communicate/mitigate impact to cross functional groups Own deviations and leads investigations / CAPA development Qualified as a deviation Lead investigator, responsible for medium and high complex investigations across all manufacturing unit operations. Lead investigator (medium and complex investigations > technical, compliance and EHSS investigations) Qualified trainer for all GMP operations, closed and open operations, including all grade B aseptic handling. Owner of GMP documentation, controlled documents and batch records. Responsible for manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements Solve complex problems; takes new perspectives using existing solutions. Operational trouble shooting Production planning to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts as needed Maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area