Manager, Senior Manufacturing Support Specialist

<p>Working with Us<br/>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 rich in diversity. Take your career farther than you thought possible.</p><p></p><p>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: <a href="https://careers.bms.com/working-with-us" rel="noopener noreferrer" target="_blank">careers.bms.com/working-with-us</a>.</p><p></p><p></p><p>Bristol Myers Squibb Ireland</p><p>Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units</p><p>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.</p><p>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, 2021 and 2022.  </p><p></p><p>Position Summary</p><p>BMS Cruiserath Biologics is seeking to recruit a Senior Manufacturing Support Specialist to support the start-up of our commercial drug product manufacturing facility for its biologics commercial portfolio and clinical pipeline. </p><p></p><p>Reporting to the Senior Manager of Operations, the Senior Manufacturing Support Specialist will play a key role in the establishing our multi-product commercial Drug Product Facility with both vial and syringe fill finish technology. This shall be achieved by providing technical leadership and input into all phases of the project, such as, CQV, Site Operational Readiness, Technical Transfer, new product introduction and commercialization activities. The successful candidate shall work to implement RFT culture with SDP during start-up.</p><p></p><p>Post start-up this role will be embedded within the Manufacturing Support team charged with supporting the Operational teams e.g., provide leadership in OE principles, lead complex investigations, support batch disposition and support new product introductions.</p><p></p><p>The start-up nature of this project will require adaptability &amp; innovation due to the multiple project phases and multiple products onsite. The role will be both challenging &amp; rewarding and will thus ensure that the successful candidate can seize a wide range of development opportunities within BMS.</p><p></p><p></p><p>Key Responsibilities During Start Up</p><ul><li>Senior Manufacturing Support SME for Sterile Drug Product processes such as Formulation, Filling, Lyophilization, Capping and Visual Inspection</li><li>Work with the project design, CQV, &amp; the Automation/CSV teams to facilitate the implementation of the project design and validation of the project for Drug Product Operations.</li><li>Lead/support CQV, Technical Transfer and Operational Readiness activities including but not limited to:<ul><li>MFG Ops input into CQV, Operational Readiness and Tech transfer documentation</li><li>Support the Ops teams with task-based risk assessment, SOP and OJT development</li><li>Training Material development</li><li>MES / MBR Design</li><li>Material flow, consumable design, room programming</li><li>CQV support including FAT attendance as required.</li></ul></li><li>Develop and execute training programs in support of multiproduct manufacturing.</li><li>Development of planning and scheduling tools to support the project and future state routine operations.</li><li>Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.</li><li>Support development of the operational controls prescribed in the Contamination Control Strategy for Sterile Drug Product</li><li>Mentor and develop members of manufacturing support team.</li></ul><p></p><p>Key Responsibilities Post Project Delivery</p><ul><li>Manufacturing Support SME for Sterile Drug Product processes such as Formulation, Fill