About the vacancy
Production
Oncology & Hematology
Cell Therapy
Manufacturing
About Your Next Job
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.
About Your Next Colleagues
Our employees are passionate about making a difference in patients’ lives. This unwavering commitment gives us a distinct advantage in delivering life-saving treatments to patients, faster.
About Your Tasks and 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 disinfection regiment as required to meet global Health Authority requirements
Demonstrate a strong practical and theoretical knowledge in their work and guide team members in issue resolution
Execute operations described in Standard Operating Procedures (SOPs) and batch records
Executes transactions and process in all electronic systems
Demonstrate a strong practical and theoretical knowledge in their work
Perform tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements
Complete training assignments to ensure the necessary technical skills and knowledge
Proficient in process systems and supporting business systems setting up manufacturing areas and equipment/fixtures, as needed
Collaborate with support groups on recommendations and solving technical problems.
Ensure the shift works effectively in a team based, cross functional environment to complete all production tasks required by shift schedule
Collaborate closely with Managers to ensure seamless pass down and communication of operational status
Completes change actions for change controls or investigations
Initiates and facilitates triage calls
Identify and propose innovative solutions
Drive right first time (RFT) execution of manufacturing unit operations by providing direct training, guidance, and problem solving
Aid in daily work coordination and distribution as demanded through the production schedule
Ensure shift notes and hand over communication is complete and accurate, as needed
Leads Tier 1 and Tier 2 meetings
Delegate for manager
Drives positive attitude in team
About Your Skills and Experience
Associate or bachelor's degree in related field is preferred.
A minimum high school diploma and/or equivalent combination of education and experience is required.
Netherlands
MBO 3 of 4 in science related field and/or equivalent 4+ 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
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.
Demonstrated good interpersonal skills, is attentive and approachable.
Maintain a professional and productive relationship with area management and co-workers.
Where Molecules Meet Opportunities
Mentorship, leadership, growth and inclusion. These are just some of the benefits of a career with BMS.
Contact person
Talent Acquisition
At Bristol Myers Squibb, your work helps people prevail over serious diseases. From the scientists behind the microscope to the analysts behind the data, everyone at BMS is working to make an impact. And while our work transforms the lives of patients, it also transforms the lives and careers of our people.
This isn’t easy work, but it is uniquely interesting. You’ll rewrite the rules, solve the toughest challenges, and create miracles.
The BMS Leiden manufacturing facility is our first European site for CAR T cell therapies, joining our global network of facilities transforming care for patients with blood cancer and other serious diseases. Equipped with the latest technology and state-of-the-art production facilities, the facility represents our commitment to ensuring supply of CAR T therapies.