Senior Scientist, Upstream Manufacturing Technology Tech Transfers

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 permanent Senior Scientist, Upstream Manufacturing Technology Tech Transfers as part of Manufacturing Sciences and Technology (MS&T). The Manufacturing Technology group are responsible for new product introduction, process validation and continued process technical support to unit operations for the commercial manufacture of multiple mammalian cell processes in the Cruiserath Multi Product Cell Culture facility. The successful candidate will be key contributor to a dynamic and highly technical global team. This position will build collaborations with Manufacturing, Supply Chain, Engineering, Quality Assurance, Quality Control and Global Regulatory Sciences groups. Key Duties and Responsibilities: Lead technical upstream role for a new product introduction Lead & support new product introduction, process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for the Cruiserath Multi Product Cell Culture facility. Leading a team of upstream MT scientists and engineers to deliver new product introductions in line with program schedules. Owning and driving significant cross-functional scopes of work associated with the technical transfer of new products to the Cruiserath biologics facility. Provide technical support for and manage team input to investigations and resolution of process deviations, root cause analysis, CAPAs, process improvements, change controls and preparation of regulatory filings. Strong knowledge of cGMP compliance, site and regulatory agency requirements. Assists in evaluating process performance by comparing manufacturing data to historical data from other sites. Accountable for delivery of upstream technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process. Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the Cruiserath site. Qualifications, Knowledge and Skills Required: Minimum BSc or equivalent with a minimum of 8 years’ experience in tech transfer, technical services/manufacturing technology in the biopharmaceutical industry including experience with process validation. You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills. Excellent verbal & written communications skills. Interpersonal and facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams. Proven ability to lead teams to high quality and efficient delivery in line with project timelines. You have proven problem solving ability, project management skills, including leading cross functional teams and balancing multiple project assignments. Please note that this role may (at tech transfer in-plant campaign execution support stage) require periods of extended hours or a modified work schedule and may require on-call availability 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.