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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.

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.

Bristol Myers Squibb seeks to employ a permanent Principal Scientist to join the Microbiology team at the Cruiserath Biologics campus. The Principal Scientist, QC Microbiology will have responsibility for the development and oversight of the environmental and clean utilities monitoring programs for the Drug Substance and Drug Product manufacturing facilities, the development and implementation of site strategies for maintaining environmental control of aseptic processing areas, in addition to providing technical expertise and guidance to relevant site functions in accordance with cGMP regulations.

This position will be required to support start up qualification activities for the new Cruiserath Biologics Sterile Drug Product facility, and therefore provides an excellent opportunity for someone excited about the prospect of joining a dynamic team at the beginning of a significant expansion project.

Key Responsibilities

Reporting to the Associate Director, QC Site Operations, this position will have responsibility for the following:

• Develop, maintain, and oversee the environmental and clean utilities monitoring programs for the Drug Substance and Drug Product facilities.

• Provide technical expertise in areas such as clean room environmental monitoring, encompassing viable and total particulate monitoring, clean utilities monitoring, sanitisation practices, gowning practices and general aseptic compliance aspects.

• Develop and maintain aseptic monitoring strategies for in process, intervention and end of fill operations in compliance with Annex 1 requirements.

• Oversee the trending and reporting of environmental data. This will include leading a multifunctional governance program whereby the environmental performance of the facility is assessed with key stakeholders.

• Support continuous improvement initiatives for environmental and aseptic control by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved.

• Support the review and approval of aseptic simulation protocols and reports as the Microbiology Subject Matter Expert (SME).

• Develop and maintain a training and qualification program for reconciliation and reading of media filled batches.

• Support the cleanroom behavior training program.

• Develop and maintain the biological indicator qualification and testing program.

• Develop and maintain the facilities contamination control strategy.

• Lead the disinfect efficacy testing program.

• Lead environmental monitoring performance qualification activities for the facility.

• Support technical transfer activities for STAT testing.

• Collaborate with the Microbiology Centre of Excellence and the MS&T Process Micro team, on the provision of process support and expertise relating to rapid microbiology method development and implementation into the production environment. Act as lead in driving network harmonization of methods, systems and equipment.

• Support the transfer and optimization of microbiological methods, equipment, and technology for the Microbiology Laboratory Interface with network, and industry consortiums such as BPOG, ISPE, PDA to maintain a view of the current trends and best practices for microbiology laboratory operations, environmental monitoring, and aseptic processing.

• Provide SME support on critical manufacturing investigations involving environmental and aseptic processing components, including impact assessment, root cause analysis and Corrective/Preventative Action generation.

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

• 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 vendor and contract laboratory audits, as required, supporting the provision of response to applicable microbiological citations. Act as the primary point of contact for audit discussions relating to environmental monitoring and aseptic control.

• Build and foster strong relationships within the biologics quality and global quality network to drive compliance, strengthen quality systems and support company objectives. Collaborate with network sites on technical issues to drive and maintain an aligned quality approach and foster an environment of continuous improvement.

Qualifications & Experience

• The successful candidate must possess a Bachelor in Science, Engineering or other related discipline and must have a minimum of 10 years’ experience working in the Pharmaceutical Industry. Experience working in sterile manufacturing facility is a requirement.

• Demonstrated understanding of the test methods and instrumentation associated with environmental monitoring of a biologics drug substance and drug product manufacturing facility.

• Demonstrated ability to influence work cross functionally in a dynamic and challenging environment.

• Extensive knowledge of Annex 1 and applicable US and EMA GMP regulations and guidance.

• Planning and organisations skills are required to plan, execute and manage resources against timelines and project commitments; must be able to adjust to changing priorities in 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. Additionally, the successful candidate must be able to interact with a broad range of disciplines and exert positive influence within internal matrix teams across a variety of functions.

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

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/ (https://careers.bms.com/eeo-accessibility) 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: R1580478

Updated: 2024-05-01 13:12:21.359 UTC

Location: Mulhuddart-IRL

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.