Senior Manager, QC Microbiology - Product Testing

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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.

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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

Position Summary

BMS Cruiserath Biologics seeks to employ a permanent Senior Manager, QC Microbiology to lead the QC Microbiology Product Testing team. Reporting to the Associate Director for QC Site Operations, this role will be responsible for ensuring compliance with regulatory and health and safety requirements, implementing and maintaining robust microbiological test methods, ensuring that bioburden and endotoxin testing of raw materials, utility, in process, drug substance and drug product are completed to schedule, and delivering continuous improvement initiatives in the microbiology laboratory. In addition, this role will support the expansion of the Microbiology team to deliver on qualification and routine microbiological product testing requirements for the campus’ new Sterile Drug Product facility.

Key Responsibilities

Leadership and Team Management:

• Provide leadership, coaching, guidance and expertise to Microbiology team as required to ensure objectives are met and development opportunities are maximised.

• Apply a strategic approach to the establishment of department objectives to ensure efficient operations, optimized resource management, compliance with regulatory requirements, and enable continuous improvement.

• Develop risk mitigation strategies and implement appropriate controls to minimize the impact of identified risks.

• Foster a culture of collaboration, innovation, and continuous improvement within the microbiology team.

• Set performance goals, conduct performance evaluations, and provide ongoing feedback to team members.

• Identify training needs and develop training programs to enhance the technical skills of the team.

Microbiology Laboratory Operations:

• Oversee the day-to-day operations of the microbiology laboratory, ensuring adherence to standard operating procedures (SOPs), regulatory guidelines, and safety protocols.

• Develop and implement robust microbiological test methods for bioburden, endotoxin, sterility, microbial identification, growth promotion, qPCR and MVM testing.

• Ensure timely and accurate testing raw materials, utility, in process, drug substance and drug product samples.

• Review and approve laboratory investigations, deviations, and out-of-specification (OOS) results related to microbiological testing, as required.

• Oversee and support technical transfer projects pertaining to microbiological testing.

• Collaborate with cross-functional teams to support investigations and root cause analysis of microbiological issues.

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