Manager, QC Microbiology Technical Lead

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: .

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

The Role

BMS Cruiserath Biologics is seeking to recruit on a permanent Manager, QC Microbiology Technical Lead , reporting to the Senior Manager, QC Microbiology, the person covering this position will be responsible for providing technical expertise and oversight to the Microbiology group in accordance with cGMP regulations. In addition, this is an excellent opportunity for someone who wants to come in at the start of an expansion project, and support start up qualification activities for the new Sterile Drug Product facility.

Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs.

Key Duties and Responsibilities:

• Develop, maintain, and oversee the Environmental Monitoring and Utility sampling programs and testing activities on site.
• Oversee the Trending and reporting of Environmental data, including leading the cross functional contamination environmental review team.
• Provide Technical expertise in areas such as Clean Room EM encompassing Viable (Surface, passive air, active air, personnel) and Total Particulate Monitoring, Clean Utilities Monitoring, Sanitisation practices, Gowning practices and general aseptic compliance aspects.
• Ensuring compliance with Standard Operating Procedures and Registered Specifications.
• 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.
• Tech transfer responsibilities for STAT testing as required. Experience with HPLC and UV testing would be an advantage.
• Experience with laboratory data systems such as LIMS, CIMS, LES and MODA would be an advantage.
• Lead and participate in deviations related to environmental control and identify 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.
• Provide SME expertise, review and approval of deviations, lab investigations, change control, CAPA etc.
• Review and approve technical documents for regulatory agency submissions and author responses to agency questions as required.
• Participate in and support audits, both internal and external (HPRA/ FDA etc.), including vendors and contract lab audits
• Leads and fosters an environment of continuous improvement.
• Ensures all Environmental monitoring and utility related 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,Knowledge and Skills Required:

• A degree in a science, engineering or related discipline is essential along with extensive experience of cleanrooms and utility systems in the pharmaceutical industry.
• Extensive knowledge of US and EMA GMP regulations and guidance.
• Ideally have knowledge/experience in QC Microbiology functions
• 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.

Why you should apply:

• You will help patients in their fight against serious diseases.
• You willbe part ofa 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 . Visit 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.

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