Quality Control Method Trending Lead
Posted on: 3 Jan 2021
Devens, MA
Job Description
At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Quality Control Method Trending Lead
Summary:
To support commercial biologics laboratory testing and instrument performance through Statistical process control trending.
Responsibilities:
* Monitor and analyze analytical method performance using statistical tools.
* Lead evaluations and investigations of adverse data trends.
* Support data/analysis requests for APR/APQR, investigations, and analytical method changes. Support optimization and improvements of analytical method performance data assessments and trending.
* Support data mining, collection, and verification to support local trending and network initiatives.
* Support or lead writing of technical reports independently and with cross functional subject matter experts
* Participates in audit response development and management of response timeline and CAPA identification.
* Work with IT functions to create robust data collection and analysis strategies
Qualifications:
* Minimum BS degree with 4+ years relevant life-science industry experience (pharmaceutical/biologics) preferably in a QC environment.
* Knowledge of biologics laboratory settings, GMPs, and support disciplines and the basic principles of each. Knowledge and understanding of regulatory and technical data trending requirements and associated processes.
* Strong understanding/knowledge of Discoverant, SAP, Sample Manager, LES, Empower and Infinity preferred.
* Project management, problem-solving and decision-making skills.
* Experience determining objectives of significant projects or assignments.
* Knowledge pertaining to data collection, management, and analysis
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
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
