Job Description

Summary:
Bristol-Myers Squibb is seeking a quality control professional to join our QC STAT team, performing QC testing in support of biologics bulk drug substance manufacturing using defined methods in a cGMP compliant laboratory. The QC Associate assures test results are accurately recorded and abnormal data or equipment/instrument malfunctions are promptly reported to his/her supervisor. The QC STAT AM team works a 12-hour shift (5AM to 5PM) with rotating work days across a 2-week period (36/48).

Responsibilities:

Performs routine testing and data review of in-process and batch release samples of Bulk Drug Substance in a cGMP compliant environment.
Performs routine assays such as UV-VIS Spectrometry, Titer, utility testing, personnel and environmental monitoring, Total Organic Carbon testing, and more complex assays including various HPLC methodologies (e.g., sialic acid).
Performs broad range of troubleshooting techniques and leads such within area of expertise.
May write and revise SOPs for managerial review and approval.
May train less experienced analysts on basic and some more complex test methods.

Qualifications:

Knowledge of science generally attained through studies resulting in a BS degree, preferably in Chemistry, Molecular Biology, or related discipline.
A minimum of 0-2 years of experience in a Biologics QC laboratory or related biopharmaceutical cGLP or cGMP lab.
Experience in analytical test methods such as UV/Vis, HPLC, TOC, and protein purification highly preferred.
Knowledge of lab software applications (e.g., LIMS, ELN (LES/SmartLab), Empower) preferred.
Excellent manual dexterity including proficiency in aseptic techniques desired.
High attention to detail with strong general laboratory and good organizational skills.
Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints.
Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices.
Demonstrates problem solving and analytical thinking skills.

Work Environment:

QC Associates will work in teams and have continual interaction with members of his/her team as well as other teams throughout the facility in order to exchange information regarding testing completed, in process and planned. 
All QC Associates will have daily contact with her/his supervisory staff for work assignments, coaching and general management discussions. Incumbents normally receive general instructions on routine work and specific instructions on new assignments.
Occasional contact with other line management staff relating to specific project responsibilities may be expected.
QC Associates primarily work in a cGMP laboratory and follow techniques which require one to be alert, giving a high attention to detail, and to properly use Personal Protective Equipment (PPE) when handling hazardous materials.
Work will be required on weekdays, weekends, holidays, and during adverse weather conditions in support of manufacturing facility. This is a 12-hour (5am-5pm) rotating shift.  Occasional overtime work may be required.