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Senior specialist, qcss instrumentation

Bristol Myers Squibb
Posted: 5 April
Offer description

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.
Take your career farther than you thought possible.
Bristol Myers Squibb Ireland Bristol Myers Squibb has been in operation in Ireland since ****, 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 ****" in the Irish Pharma Industry Awards and is certified as a Great Place to Work since ****, including as a Great Place to Work for Women in **** and ****.
The Role BMS Cruiserath Biologics is seeking to recruit on a permanent contractSenior Specialist, QCSS Instrumentation, reporting to Manager, QC Instrumentation Team Lead, QC Analytical Shared Services.
The candidate must have strong experience in all aspects of instrument management in a GMP environment, in addition to an understanding of the needs and best practices of routine biopharmaceutical drug product and drug substance laboratories.
They will have responsibility for establishment of project plans and instrument qualification procedures.
Experience in Data Integrity management (21 CFR 11/EU Annex 11) is desired.
A strong fundamental understanding of protein biochemistry is desirable, in addition to technical expertise in the following Biopharmaceutical analytical platforms (HPLC/UPLC, CE, cIEF, SDS-PAGE, Biacore, HIAC, KF, Liquid Handlers).
Key Duties and Responsibilities: Providing a Calibration and/or Maintenance Service to the QC laboratory that includes instrumentation calibrations, scheduling and tracking of instrument maintenance and instrument lifecycle management.
Review and approve analytical instrumentation qualification, calibration, repairs and documentation.
Ensure instrument maintenance and verification is appropriate to the use of the instrument Manage all instrument specific investigations such as calibration deviations Trend lab instrument performance and lifecycle management.
Participate in new instrument purchase and qualifications Participate as part of a team of QC Specialists, QA validation Specialists and Computer System Validation personnel to deliver on the qualification of new instruments.
• Liaise with sister sites and vendors on instrumentation purchase, qualification and lifecycle management.
Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, calibration and lifecycle management.
Participate in definition and establishment of instrument related procedures.
Participate in troubleshooting complex instrumentation issues.
Qualifications, Knowledge and Skills Required: The ideal candidate should hold a minimum of a B.Sc.
in scientific related discipline and must have at least 3 year's experience, at least 1 of which should be related to instrument qualification experience in a GMP laboratory setting.
Previous experience in technology transfers would be advantageous.
The successful candidate must demonstrate the ability to contribute to and lead in a team based collaborative environment, as well as the ability to prioritise objectives from multiple projects.
The successful candidate must demonstrate time management and organisational skills and excellent communication is essential.
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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