Manager, QC Microbiology

1 month ago


Mulhuddart, Ireland Bristol Myers Squibb Full time

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, 2021 and 2022.  

Position Summary

Cruiserath Biologics is seeking a permanent QC Microbiology Manager to lead the Environmental and Utilities team. Reporting to the Senior Manager, QC Microbiology, they will lead a team of QC Microbiology Analyst’s supporting site activities related to EM, Utilities and In-process testing in the drug substance manufacturing facility. 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 Environmental Monitoring, Utility sampling, Biological indicators and In-process 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 Environmental Monitoring
  • 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.

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 an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym

#LI-Hybrid

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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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.