QC STAT Associate (AM Shift)
Posted on: 17 Jan 2022
Devens, Massachusetts
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.
Bristol-Myers Squibb
New York, New York
Bristol-Myers Squibb Company discovers, develops, licenses, manufactures, markets, distributes, and sells biopharmaceutical products worldwide. The company offers drugs in oncology, immunoscience, cardiovascular, and fibrotic diseases. The company’s products include Opdivo, a biological product for anti-cancer indications; Eliquis, an oral inhibitor targeted at stroke prevention in adult patients with non-valvular atrial fibrillation, and the prevention and treatment of venous thromboembolic disorders; and Orencia, a biological product for adult patients with moderately to severely active RA and prostate-specific antigen, as well as reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular juvenile idiopathic arthritis.
It also provides Sprycel, a tyrosine kinase inhibitor for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia; Yervoy, a monoclonal antibody for the treatment of patients with unresectable or metastatic melanoma; Empliciti, a humanized monoclonal antibody for the treatment of multiple myeloma; and Baraclude, an oral antiviral agent for the treatment of chronic hepatitis B. In addition, the company offers Reyataz, a protease inhibitor for the treatment of human immunodeficiency virus (HIV) and Evotaz; Sustiva franchise, a non-nucleoside reverse transcriptase inhibitor for the treatment of HIV; and Daklinza NS5A replication complex inhibitor, Sunvepra NS3 protease inhibitor, and Beclabuvir NS5B inhibitor. It sells products to wholesalers, retail pharmacies, hospitals, government entities, and medical profession. It has collaboration agreements with Nektar Therapeutics; Janssen Pharmaceuticals, Inc.; Biocartis Group NV.; and FameWave Ltd.
The company was formerly known as Bristol-Myers Company and changed its name to Bristol-Myers Squibb Company in 1989. Bristol-Myers Squibb Company was founded in 1887 and is headquartered in New York, New York.
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IndustryBiopharmaceuticals
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No. of Employees23, 300
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Website
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Jobs Posted1641
