Specialist, QC Release (Trending)

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 QC Release Specialist (Trending) reporting to the QC Release Trending Lead mainly responsible for managing routine Method Performance Monitoring, Out of Trend Assessments, completion of APQRs, Trend reports and overall ownership of the QC Trending Program. Key Duties and Responsibilities: Responsibility for defining, scheduling, coordinating, and driving to completion of all QC required sections for Annual Product Quality Review (APQR) reports. Responsibility for defining, scheduling, coordinating, and driving to completion all Annual Trend Reports. Support harmonisation of trending across BMS network sites. Responsibility for oversight and management of the Method Performance Monitoring Program, incorporating Reference Standard monitoring and invalid rate tracking. Management of trend related investigations, in association with the QC Analytical Trending Lead. Point of contact for internal and external manufacture sites, attend meetings where necessary. Co-ordination of trend assessments with the relevant SME’s and ensure delivery to meet due dates. Review trend limits from the manufacturing site and ensure timely implementation at CRU QC e.g LIMS. Addition of new products to the trending programme post successful transfer to the CRU QC teams. Compliance with Standard Operating Procedures and Processes. Approval of SOPs, trend data, non-conformances and reports. Participate in regulatory agency inspections as required. Supporting Network teams as they pertain to QC Trending. Manage and contribute to the achievements of department productivity and quality goals. Participate in QC Release ad-hoc activities as required to support QC Qualifications, Knowledge and Skills Required: Minimum of a BSc in Biochemistry or related discipline Minimum of 3 years hands on experience in a GMP Laboratory Setting, QC Trending experience is advantageous, preferably Biologics A strong fundamental understanding of protein biochemistry is desirable. Technical expertise should include the following Biopharmaceutical analytical platforms (HPLC/UPLC, CE, cIEF, SDS-PAGE, Biacore, Bioassay) and compendial techniques (KF, HIAC) Previous experience with analytic laboratory data systems (Electronic Notebook, Velquest) would be advantageous. The successful candidate must demonstrate a problem-solving ability, as well as the ability to prioritise objectives from multiple projects. The successful candidate must demonstrate excellent time management and organisational skills. Excellent communication and the ability to contribute to and lead in a team based collaborative environment is essential. 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.