Senior Principle Scientist , Sterile Drug Product Aseptic Process (Manufacturing, Science & Technology)

<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>The incumbent will provide sterility oversight to ensure of the aseptic filling process and Quality &amp; Regulatory Compliance for the aseptically manufactured products, processes &amp; systems occurs in accordance with Regulations and BMS requirements. As part of the role, she/he will be managing the team to qualify the Media Fill (Aseptic Process Simulations) in the new Sterile Drug Product facility on site reporting directly to the Senior Director SDP MS&amp;T.</p><p></p><p>This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.</p><p><br/><br/>Key Responsibilities</p><p></p><ul><li>Program owner for all media fill activities associated with the new Sterile Drug Product facility.</li><li>Hiring, Managing, and building the team to execute and deliver Media Fills within the new Sterile Drug Product facility.</li><li>Technical support of Contamination Control Strategy, Contamination Control Risk Assessments, Smoke Studies, Environmental Monitoring Trend Analyses, Aseptic Training, and Qualification programs within the new Sterile Drug Product facility.</li><li>Participates in Health Authority inspections (HPRA, EMEA, FDA, and International Authorities) which includes managing the requests and responses, providing updates, and adherence to the regulatory commitments.</li><li>Active role owner in various audit preparation for the site, including the assistance in the generation of responses and owning the Sterility Assurance relevant CAPAs and Media Fills.</li><li>Supports the Field Alerts reports (FAR) and Biologic Product Deviation Reports (BPDR) as needed.</li><li>Provides input, where required, for all deviations with respect to the Sterility Assurance and the Aseptic Manufacturing Process. </li><li>Works closely on resolution of critical Sterility Assurance issues that can impact supply continuity of critical medication to patients.</li><li>Assure that the sterility compliance state of control is maintained by creating and sustaining a high commitment to quality and compliance and works proactively with the different Quality and Operations stakeholders.</li><li>Ensures budgets development and the preparation of periodic projections of spending against budgets for the assigned activities.</li><li>Anticipates and actively monitors regulatory trends and best practices in the industry and implements at the site as applicable using simplistic and innovative approach.</li><li>Ensure site cGMP required procedures are in alignment and compliance with BMS Corporate Compliance and Headquarters Polices and Directives.</li><li>This position requires approximately 10% travel to regional headquarters, or any other business travels as assigned.</li></ul><p></p><p><br/>Qualifications &amp; Experience<br/> </p><ul><li>BS in Life Sciences (Microbiology, Pharmacy, Biology, or a relate