Manager, QC Separations Supervisor

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Bristol Myers Squibb Ireland Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company’s first European biologics manufacturing facility. This state of the art facility will produce multiple therapies for the company’s growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus. BMS Cruiserath has been awarded “Biopharma Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020 and 2021. For more information about Bristol Myers Squibb, visit us at BMS.com/ie The Role BMS Cruiserath Biologics is seeking to recruit a Manager, QC Separations Supervisor for the QC Separations team. This role is a 9 month Fixed-Term Contract for maternity leave cover. Reporting to the QC Separations Senior Manager, the Manager, QC Separations Supervisor will manage a team of analysts within the QC Separations team for the Global Biologics Laboratory. The successful candidate will be responsible for leading and the coordination of analytical testing with responsibilities for oversight of scheduling of testing, approval of results and COA generation. Key Duties and Responsibilities: Leading and engaging a team of QC analysts and senior analysts and recruiting where necessary. Responsibility for on time finished product and drug substance release testing and laboratory documentation, responsible for the oversight of lab scheduling for all QC activities for Global Biologics Laboratory to ensure adherence to TAT metric, Use of OPEX tools to maximise efficiencies and adequately support production and other departments. Establish a robust training programme for laboratory personnel. Co-ordination of consumable inventory with external stakeholders and Vendor Managed Inventory stakeholders. Compliance with Standard Operating Procedures and Registered Specifications. Management of laboratory investigations associated with atypical/OOS results and laboratory deviations related to the testing of commercial product. Approval of SOPs, trend data, validation protocols, validation/verifications and equipment qualifications. Oversight of sample management within the laboratory, electronic and paper logbooks and LIMs data. Maintain within the QC Separations laboratory, current corporate and industry requirements and compliance trends as they pertain to laboratory operations. Participate in regulatory agency inspections as required. Ensure all laboratory activities are conducted in a safe manner. Qualifications, Knowledge and Skills Required: A minimum of a B.Sc. in Biochemistry or related discipline and must have at least 5 years’ experience, in a GMP laboratory setting with QC release testing. Understanding of the needs and best practices of routine biopharmaceutical drug product and drug substance laboratories is desirable, strong background in chromatography and aseptic manufacturing is an advantage. Demonstrate leadership ability and flexibility along with good communication and team-work skills. Excellent communication skills are critical. Ability to communicate on a global level is required, in addition to meeting management skills. The candidate must have experience in electronic systems such as LIMs/CIMs and Trackwise/Infinity. Demonstrated experience in corporate and regulatory audits. What’s important to us Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases: Passion: Our dedication to learning and excellence helps us to deliver exceptional results. Innovation: We pursue disruptive and bold solutions for patients. Urgency: We move together with speed and quality because patients are waiting. Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments. Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues. Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential. We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve. Why you should apply You will help patients in their fight against serious diseases You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees. You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days, life assurance, on-site gym and gain-sharing bonus. BMSBL 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.