**Working with Us** 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. 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: careers.bms.com/working-with-us . **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 on a permanent contract Senior Specialist, QC Trending, reporting to Manager, QC Trending. 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:** + 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 and QC Trending experience is preferable, 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. **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, but not only, an annual bonus, pension contribution, family health insurance, 27 days annual leave, access to BMS Cruiserath on-site gym and life assurance. BMSBL **\#LI-Hybrid** If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. **Uniquely Interesting Work, Life-changing Careers** With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. **On-site Protocol** BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. **Company:** Bristol-Myers Squibb **Req Number:** R1585664 **Updated:** 2024-09-24 04:46:05.515 UTC **Location:** Cruiserath-IE Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.