Manager, Technical Lead, Sterile Drug Product

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.

Summary BMS Cruiserath Sterile Drug Product is seeking an experienced individual with aseptic manufacturing experience to provide on the floor technical leadership to our manufacturing teams within our new Sterile Drug Product (SDP) facility. Reporting to the Senior Manager, Manufacturing Shift Lead, the Sterile Drug Product Technical Lead will play a key role in the establishing our multi-product commercial Drug Product Facility with both vial and syringe fill finish technology. The SDP Technical Lead will provide technical input into all phases of the SDP project, such as, CQV, Site Operational Readiness, Technical Transfer, new product introduction and commercialization activities.  Post start-up this role will be embedded within the shift teams charged with delivering the manufacturing plan for the facility. The start-up nature of this project will require adaptability & innovation due to the multiple project phases and multiple products onsite. The role will be both challenging & rewarding and will thus ensure that the successful candidate can seize a wide range of development opportunities within BMS. The position will commence on a day schedule, with a planned transition to shift work in the future Key Responsibilities Manufacturing SME in one or more processes that include Formulation, Filling (vial & syringe), Lyophilization, Capping, Visual Inspection & Primary Packaging Lead technical issue troubleshooting, resolution both during and post facility start-up. Work with the cross functional departments to facilitate the implementation of the project design and validation of the SDP manufacturing facility. Support all phases of Commissioning / Qualification and Validation during Start up phase of state of the art Drug Product Facility Support all Capital / Tech Transfer / Operational Readiness activities including but not limited to: Vendor site Factory Acceptance Tests MES / MBR Design SOP Development and Implementation Training Material development Room layouts and Ways of Working Support delivery of training to SDP team on day-to-day operations within area of responsibility Work in conjunction with the Shift Lead/Technical Lead to build the SDP Manufacturing teams technical competencies across a given area. Lead the Right First-Time execution of commercial manufacturing processes within areas of responsibility. Support key meetings on behalf of Manufacturing. Support and Lead key Operational Excellence initiatives (5S / Std Work / LSW / Kaizen / Problem Solving etc) Support Operational related investigations and bey the key point of contact for all other functional investigations. SME in use of process automation systems (i.e., Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.e., SAP. Trackwise, Maximo etc.). Co-ordinating delivery review of batch and exception reports for manufacturing lots in conjunction with Quality Assurance representative for area of responsibility Drives and supports culture of continuous improvement initiatives and safe working practices. Designee for Tech Lead, when required. Support any other business deliverables as needed. undefined Qualifications & Experience A Bachelors in a science, engineering, or related subject is desirable Minimum 3 years’ experience in a GMP environment with a minimum of 1 years’ biopharma manufacturing experience Expertise in sterile drug product manufacturing