QC STAT Team Lead

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QC STAT Team Lead

Bristol-Myers Squibb is seeking an experienced quality control professional for the position of QC STAT Team Day Shift Lead to work a 12 hour (36/48) rotating shift (5AM to 5PM).

Qualifications:

• Knowledge of science generally attained through studies resulting in a BS/MS Degree or equivalent, preferably in Chemistry or Biological Sciences.

• Minimum of 6 years’ experience in Biologics QC laboratory or related biopharmaceutical cGMP lab.

• Strong chemistry background is preferred with proficiency and/or mastery of one or more of the following test methods:  Sialic Acid, A280, TOC, Titer, AKTA purification.

• Thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to quality control laboratories in a biologics manufacturing facility. Can effectively interact with inspectors during lab tours.

• Experience in interpreting and applying cGMPs, USP/compendia, regulatory requirements and industry best practices.

• Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints.

• Proficient in lab software applications (e.g., LIMS, ELN (LES/SmartLab), Empower).

Responsibilities :

• Lead a day shift team of analysts.  This individual will have continual interaction with members of his/her team as well as other teams throughout the facility to exchange information regarding testing completed, in process and planned.  The team lead will have daily contact with her/his supervisory staff for work assignments, coaching and general management discussions.

• Work in a cGMP laboratory and follow techniques which require one to be alert, giving a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials.  As essential personnel, when on shift, the applicant will be required to work holidays, during inclement weather, and occasional overtime to meet project timelines when required.

• Observant of their work area and related tools and identify and report any discrepancy from normal practice or procedure, recommending and implementing corrective actions. 

• Perform routine assays such as UV-VIS Spectrometry, TOC, and more complex assays including various HPLC methodologies, as well as lead equipment troubleshooting activities and investigate out of specification results.  Individual may support method transfer testing.   

• Perform data review of in-process and Bulk Drug Substance samples in a cGMP compliant environment.

• Train less experienced analysts on basic and complex test methods.

• Write and revise SOPs for managerial review and approval as well as write technical reports (for example Investigations or Qualification) and perform data analysis and trending for both method transfers and investigations.

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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
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