Technical Lead Manufacturing, Cell Therapy

Job description

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 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 Qualifications/Education/Experience/Licenses/Certifications: 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. Preferred Experience: Experience in cell therapy manufacturing, including Cell washing processes and automated equipment. Cell separation techniques and automated equipment. Cryopreservation processes and equipment. 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)This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to de