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.

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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, 2021 and 2022.

Position Summary
Cruiserath Biologics is seeking a permanentQC Microbiology Technical Leadto support the Product Testing team.
The QC Microbiology Technical Lead will be responsible for providing technical expertise and oversight to the Microbiology group in accordance with cGMP regulations and oversee testing programs on site for the Drug Substance facility here in Cruiserath.
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.

Key Responsibilities
Reporting to the Senior Manager QC Microbiology, this position will have responsibility for the following:
Manage the testing programs ensuring compliance with regulatory and corporate directives for the QC Microbiology laboratory that support the MPCC facility and Release testing Global Biolab at Cruiserath
Provide technical leadership and guidance to the QC Microbiology team on the establishment of the laboratory procedures and practices, quality system elements, method verifications, equipment qualifications, and cross-functional Microbiology support for the MPCC facility and SDP facilty.
Technical expertise in the following: Endotoxin testing, Bioburden testing, qPCR, Microbial Identification, Growth Promotion, and general Microbiology laboratory techniques.
Knowledge of MVM, IVV and Mycoplasma testing would be an advantage.
Leading method verifications for new materials and NPIs
Participate in cross-functional teams to establish and maintain microbial control including network interaction to ensure alignment across sites as part of Microbiology center of excellence.
Oversee the Trending and reporting of Microbial data, including leading the cross functional microbial data review team.
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.
Experience with laboratory data systems such as LIMS, CIMS, LES and MODA would be an advantage.
Lead and provide SME expertise in deviations/lab investigations/change controls related to the product testing team 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.

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 product testing 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 & Experience
A degree in a science, engineering or related discipline is essential along with extensive experience of Bioburden and Endotoxin 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.

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

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 workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries ******. Visitcareers.bms.com/eeo-accessibilityto access our complete Equal Employment Opportunity statement.

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