Manager, QC Microbiology

<p>Working with Us<br/>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.</p><p></p><p>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: <a href="https://careers.bms.com/working-with-us" rel="noopener noreferrer" target="_blank">careers.bms.com/working-with-us</a>.</p><p></p><p></p><p>Bristol Myers Squibb Ireland</p><p>Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units</p><p>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.</p><p>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, 2021 and 2022.  </p><p></p><p>Position Summary</p><p></p><p>Cruiserath Biologics is seeking a QC Microbiology Manager on a fixed term contract 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.  </p><p></p><p>Key Duties and Responsibilities</p><p>Reporting to the Senior Manager QC Microbiology, this position will have responsibility for the following:</p><ul><li>Responsibility for all QC Microbiology tasks related to Bioburden, Endotoxin, Microbial Identification, Growth Promotion, qPCR and MVM testing.</li><li>Ensuring compliance with Standard Operating Procedures and Registered Specifications.</li><li>Supervision of laboratory personnel and adjustments to schedules to maximise efficiencies and provide an effective and efficient service to support manufacturing and other departments.</li><li>Provide coaching, guidance and expertise to Microbiology team as required to ensure objectives are met and development opportunities are maximised.</li><li>Leads and fosters an environment of continuous improvement.</li><li>Experience with laboratory data systems such as LIMS, CIMS, LES and MODA would be an advantage.</li><li>Participate in investigations, deviations related to testing and identify laboratory practices and procedures for further development / improvement.</li><li>Keeps abreast of current corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.</li><li>Ownership/Approval of SOPs, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.</li><li>Participate in regulatory agency inspections and ensures lab readiness as required.</li><li>Conduct performance appraisal reviews and provide feedback for direct reports</li><li>Plan and implement procedures/processes and systems to maximise operating efficiency.</li><li>Ensures all activities are completed in a safe and compliant manner</li><li>Builds and fosters strong relationships within the biologics quality and global quality network to drive compliance, strengthen quality systems and support company objectives.</li></ul><p></p><p>Qualifications Knowledge and Skills Required:</p><ul><li>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</li><li>Knowledge of US and EMA GMP regulations and guidance.</li><li>Ideally have knowledge/experience in QC Microbiology functions in particular Bioburden and Endotoxin Testing</li><li>Experienc