Cruiserath, IE, IRL
1 day ago
Manager, 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 is a leading global biopharma company focused on discovering, developing and delivering innovative medicines for patients with serious diseases in areas including oncology, haematology, immunology, cardiovascular and neuroscience. Our employees work every day to transform patients' lives through science. Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units. Many of the global business services, including the European Treasury Centre, Market Supply Operations and Commercial Operations have a presence in Ireland. Ireland is also home to External manufacturing's global headquarters, the business unit responsible for the management of manufacturing contract operations (CMO's) and ensuring reliable supply of product to patients across the Bristol Myers Squibb global network. 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. For more information about Bristol Myers Squibb, visit us at BMS.com/ie **Position Summary** Cruiserath Biologics is seeking a QC Microbiology Manager on a permanent basis to lead the Product Testing team. Reporting to the Senior Manager, QC Microbiology, they will lead a team of QC Microbiology Analyst's supporting site activities related to Bioburden and Endotoxin testing of utilities, in-process, drug substance and drug product in the Microbiology Laboratory. In addition, this role will support expansion of the Microbiology team to support the qualification and routine activities for the new Sterile Drug Product facility. **Key Responsibilities** Reporting to the Senior Manager QC Microbiology, this position will have responsibility for the following: + Responsibility for all QC Microbiology tasks related to Bioburden, Endotoxin, Microbial Identification, Growth Promotion, qPCR and MVM testing. + Ensuring compliance with Standard Operating Procedures and Registered Specifications. + Supervision of laboratory personnel and adjustments to schedules to maximise efficiencies and provide an effective and efficient service to support manufacturing and other departments. + Provide coaching, guidance and expertise to Microbiology team as required to ensure objectives are met and development opportunities are maximised. + Leads and fosters an environment of continuous improvement. + Experience with laboratory data systems such as LIMS, CIMS, LES and MODA would be an advantage. + Participate in investigations, deviations related to testing and identify laboratory practices and procedures for further development / improvement. + Keeps abreast of current corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing. + Ownership/Approval of SOPs, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications. + Participate in regulatory agency inspections and ensures lab readiness as required. + Conduct performance appraisal reviews and provide feedback for direct reports + Plan and implement procedures/processes and systems to maximise operating efficiency. + Ensures all activities are completed in a safe and compliant manner + Builds and fosters strong relationships within the biologics quality and global quality network to drive compliance, strengthen quality systems and support company objectives. **Qualifications & Experience** + A degree in a science, engineering or related discipline is essential along with a minimum 5 years' experience of QC Laboratories in the pharmaceutical industry + Knowledge of US and EMA GMP regulations and guidance. + Ideally have knowledge/experience in QC Microbiology functions in particular Bioburden and Endotoxin Testing + Experience in GMP and GLP guidelines + Planning and organizing skills are required to plan, execute and manage resources against timelines and project commitments; must be able to adjust to changing priorities and a dynamic work environment. + Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written. The candidate will have demonstrated good project management abilities, proven decision making ability and the ability to work well with and influence all levels of management and staff. **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 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 scienceā„¢ , 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:** R1589040 **Updated:** 2025-01-31 03:16:25.258 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.
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