Projects Manager, QC Site Operations

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 fixed term 12 months QC Site Operations Projects Manager to lead the QC Site Operations Tech Transfer Projects at its Multi-Product Cell Culture Drug Substance Facility. Reporting to the QC Site Operations Projects Senior Manager, they will manage the Technical Transfer of new products incoming into QC Site Operations and QC Release Laboratories. This role entails supporting insourcing of new products into laboratories as per agreed timelines to support the Cruiserath Biologics manufacture schedule or support of testing for products manufactured at other BMS sites Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs Key Duties and Responsibilities: Project management and co-ordination of QC technical transfers for new products to QC laboratories, inclusive of raw material, cleaning validation, in process and DS methods. Oversight of all ongoing transfers (not managed by self) to QC department and ensure adherence to agreed timelines. Provide escalations where required and facilitate/drive resolution across relevant teams. Definition of Transfer Strategy for new products to QC laboratory. Support resource management for tech transfer insourcing across QC teams. Point of Contact for QC Technical Transfer at cross functional meetings. Ensure Laboratory Readiness across QC departments to support testing. Ownership of the Transfer Process for QC e.g SOP management. Support tech transfer standardisation and process improvements as required. Compliance with Standard Operating Procedures and Registered Specifications. Ensure the laboratory is operated in a safe manner and a Safety culture is embedded within the team. Keeps abreast of current corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing. Approval of SOPs, trend data, non-conformances, Transfer plans, validation protocols, reports, method verifications and equipment qualifications where required. Participate in regulatory agency inspections as required. Complete performance appraisal reviews of direct reports & identify requirements for development of colleagues. Strategically plan and implement procedures and systems to maximise operating efficiency through the use of Operational Excellence tools. Qualifications, Knowledge and Skills Required: The successful candidate must demonstrate excellent written and verbal communication skills and experience of working with teams and influencing decisions. Experience leading cross-functional teams and knowledge of applicable regulatory requirements is desirable. The ideal candidate should hold a minimum of a third level qualification (Degree) in Science or related discipline along with 5 years of experience in a pharmaceutical/ healthcare laboratory or related technical function with at least 1 year of management/supervisory experience. A strong background in Quality, Technical Transfer and aseptic manufacturing is required. 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
LI-Hybrid 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.