Job Information
Bristol Myers Squibb Senior Manager, QC Microbiology - Product Testing in Cruiserath, Ireland
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
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.
Compliance and Regulatory Affairs:
Ensure compliance with relevant regulatory requirements, including but not limited to cGMP, FDA, EMA, and other applicable guidelines.
Stay updated with industry trends, regulatory changes, and best practices in microbiology testing.
Participate in regulatory inspections and audits, providing necessary documentation and support.
Drive continuous improvement initiatives to enhance laboratory processes, systems, and compliance.
Keeps abreast of current corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.
investigations.
Qualifications & Experience
Bachelor's or Master's degree in Microbiology, Biology, or a related field. A Ph.D. is preferred.
Minimum of 8-10 years of experience in a microbiology laboratory, with at least 3 years in a managerial role.
Strong knowledge of microbiological testing methods, including environmental monitoring, microbial identification, and microbial enumeration.
In-depth understanding of cGMP regulations and regulatory requirements related to microbiology testing, in particular Annex 1 and Annex 2.
Experience with regulatory inspections and audits is highly desirable.
Excellent leadership, communication, and interpersonal skills.
Strong problem-solving and decision-making abilities.
Ability to manage multiple priorities and work effectively in a fast-paced environment.
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.
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.
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
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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/ 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.
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: R1582917
Updated: 2024-07-01 04:14:08.192 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.