Senior Specialist, Qc Materials - Contract Laboratory Management

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

The Role

BMS Cruiserath Biologics is seeking to recruit on a permanent basis aSenior Specialist, QC Materials, Contract Laboratory Management, reporting to the QC Materials, Contract Laboratory Management Manager. The Senior Specialist will manage the day to day activities relating to Contract Test Laboratory Management to ensure quality/service agreements and project timelines are met, and also method & specification management.

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:
Management of CTL forecasting for various sample types.

Tracking sample shipments and testing status at contract test labs.

Results entry from CTL CoA in electronic laboratory system.

Coordination of contract test lab method and specification updates.

Managing investigations and deviations in QC and the CTL's, in conjunction with Technical Lead, area SME's

Prioritization of workload in the CTL's.

Communication to BMS global and local stakeholders on status of testing in CTL's.

Support process improvements to standardize the management of all CTL's.

Participate in the OpEx strategy and support process improvements.

Support additional QC activities, as required.

Management of method & specification Management and Compendial Updates.

Gather feedback from all areas impacted by changed proposed for implementation.

Inform relevant groups (e.g.: bioassay or raw materials) on the proposed/implemented changes and support completion of impact assessments.

Provide feedback to global Compendial Affairs team within the due date.

Track relevant quality records to maintain implementation of the change in QC at BMS Cruiserath.

Update relevant local procedures if applicable.

Qualifications, Knowledge and Skills Required:
The ideal candidate should hold a minimum of a B.Sc. in Biochemistry or related discipline.

Must have at least 3 years' experience, in a GMP laboratory setting ideally within a biologics laboratory.

Excellent communication skills are critical.

The successful candidate must also demonstrate excellent time management and organisational skills.

An understanding of the needs and best practices of routine biopharmaceutical drug product and drug substance laboratories is desirable, in particular raw materials and microbiology testing requirements.

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 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.

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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:https://careers.bms.com/california-residents/

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