Technical Lead Manufacturing, Cell Therapy

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 describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. #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. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1602962 : Technical Lead Manufacturing, Cell Therapy