Senior Specialist, QC Microbiology

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 a Senior Specialist, QC Microbiology as a full time employee within the QC Microbiology Laboratory. Reporting to the QC Microbiology Manager, the QC Senior Specialist Microbiology will be responsible for supporting site activities related to Product Testing and Environmental/Utility Monitoring, performing testing of samples and laboratory duties in accordance with cGMP regulations Key Duties and Responsibilities: Performing Bioburden testing on Utility samples, Drug Substance and Raw Materials. Performing Bacterial Endotoxin Testing on Utility samples, Drug Substance and Drug Product. Carrying out the Minute Mouse Virus by PCR and quantitative PCR (qPCR) testing of in-process samples. Performing QC Environmental Monitoring in Classified Areas (including lot related monitoring), Utility Sampling (Including WFI and Clean Steam), associated testing of samples and completion in a timely and accurate manner of laboratory documentation as directed by the Microbiology Manager. Perform compendial verification, method transfer/validation, and routine testing of in-process, drug substance and drug product samples in accordance with applicable procedures and cGMP requirements. Delivery of training to QC Microbiology Specialists, documenting training per procedural and cGMP requirements. Supporting investigation/deviation/CAPA tasks. May lead projects and continuous improvement efforts. Anticipate and troubleshoot problems. Assisting in authoring and reviewing documentation, including SOPs, as required. Provide support to other departments to ensure qualification and production schedules are adhered to. Keeps abreast of current corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing. Batch paperwork review, and reconciliation of analysis performed in laboratory. Ensuring that any out of specification results are investigated according to site procedures. Ensuring a high standard of housekeeping and safety is maintained in the laboratory. Performing any other activities as indicated by the Microbiology Manager. Qualifications, Knowledge and Skills Required The ideal candidate should hold a minimum of a third level qualification (Degree) in Microbiology or related discipline along with at least 2/3 years of experience in a pharmaceutical / healthcare laboratory or related technical function. A strong background in Microbiology and aseptic manufacturing is required. Prior experience in PCR is desirable. The successful candidate must demonstrate excellent written and verbal communication skills. Ability to work on own initiative with minimum supervision is essential. The ability to work in a team based collaborative environment is essential. Knowledge of aseptic technique within a laboratory environment. Hands on experience with various microbiology techniques. Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. Ability to represent the interests of the group on cross-functional teams. Strong ability to communicate effectively with peers, department management and cross- functional peers. Working knowledge of onsite systems e.g., LIMS, LES and MODA highly desirable. Note: This candidate may be required to work a 24/7 or 12/7 shift pattern BMSBL
LI-Onsite 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 Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.