🇳🇱 Leiden, Netherlands · 18h ago
Technical Lead Manufacturing, Cell Therapy
Bristol Myers Squibb
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At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.Bristol Myers Squibb NetherlandsBristol 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/nlPosition SummaryOur 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/ResponsibilitiesExecute operations described in Standard Operating Procedures (SOPs) and batch recordsLead 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 groupsOwn deviations and leads investigations / CAPA developmentQualified 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 requirementsSolve complex problems; takes new perspectives using existing solutions. Operational trouble shootingProduction planning to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts as neededMaintain 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 requirementsDemonstrate a strong practical and theoretical knowledge in their work and guide team members in issue resolutionExecute operations described in Standard Operating Procedures (SOPs) and batch recordsExecutes transactions and process in all electronic systemsDemonstrate a strong practical and theoretical knowledge in their workPerform tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirementsComplete training assignments to ensure the necessary technical skills and knowledgeProficient in process systems and supporting business systems setting up manufacturing areas and equipment/fixtures, as neededCollaborate 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 scheduleCollaborate closely with Managers to ensure seamless pass down and communication of operational statusCompletes change actions for change controls or investigationsInitiates and facilitates triage callsIdentify and propose innovative solutionsDrive right first time (RFT) execution of manufacturing unit operations by providing direct training, guidance, and problem solvingAid in daily work coordination and distribution as demanded through the production scheduleEnsure shift notes and hand over communication is complete and accurate, as neededLeads Tier 1 and Tier 2 meetingsDelegate for managerDrives positive attitude in teamQualifications/Education/Experience/Licenses/CertificationsAssociate or bachelor's degree in related field is preferred.A minimum high school diploma and/or equivalent combination of education and experience is required.NetherlandsMBO 3 of 4 in science related field and/or equivalent 4+ years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and educationExtensive knowledge of cGMP regulations and FDA guidance applicable to cell therapy manufacturingPeer-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 ExperienceExperience in cell therapy manufacturing, including Cell washing processes and automated equipment. Cell separation techniques and automated equipment. Cryopreservation processes and equipment.WORKING CONDITIONSMust be able to stand/walk for extended periods of timeMust 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 protectionRequired to carry and/or lift up to 30 pounds / 15 kg, several times a day, while handling production equipment and/or materialsRequired to push and/or pull up to 50 pounds / 15 kg, several times a day, while handling production equipment and/or materialsWork in areas that may have strong magnetsMust be able to work in a BSL2/ML1 work environment handling human blood componentsWork in areas with exposure to vapor phase liquid nitrogenMust 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.Disclaimer For any third parties or external agencSourced from LinkedIn. Relocantly aggregates public job postings; apply on the original site.