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Supervisor, QC Raw Materials

Employer
Bristol Myers Squibb Company
Location
Devens, MA, United States
Start date
Aug 9, 2019

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Discipline
Manufacturing & Production, Materials/Inventory Control, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown, Best Places to Work
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Job Details

This position provides oversight for cGMP testing for raw materials used in manufacturing processes. Position is responsible for day to day operations of laboratory and additionally responsible to provide technical input for methods.

Responsibilities:

  • Trains and mentors staff, in performing routine testing and performing non-routine testing of raw materials in support of multiple manufacturing facilities in a cGMP environment.
  • Reviews methods and procedures, to ensure compliance with corporate policies and procedures. Reviews data obtained for compliance to specifications and reports abnormalities.
  • Coordinates prioritization and scheduling of all incoming samples to ensure on time delivery to customers. Works on continuous improvements for area to increase productivity and efficiencies.
  • Provides technical and operational expertise for training and developing staff, assisting in troubleshooting and performing investigations for out of specification results.
  • Collaborates with management and Learning and Development on appropriate course content for training programs.
  • Maintains expertise in multiple test methods Represents area as SME in regulatory inspections.
  • Performs and/or participates in investigations for out of specification results.
  • Writes technical reports and reviews and revises standard operating procedures as needed.
  • Performs data analysis and trending for method transfers and process investigations.
  • Leads projects related to quality control programs as assigned Administers departmental program to assure proper calibration and maintenance of laboratory equipment and leads the investigation and troubleshooting of equipment, testing and process abnormalities.
  • Coordinates interdepartmental activities, providing technical expertise to ensure that the programs are in compliance with current industry standards.
  • Oversees outsourced analytical testing Performs as SME for the Warehouse Raw Material Sampling functions.


Qualifications:
  • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, a related discipline, or its equivalent is preferred
  • Minimum of 6 years of experience as in Biologics QC lab or experience in a related biopharmaceutical GLP or GMP laboratory. Experience as people leader is preferred.
  • Expertise with raw material test methods in accordance with USP, EP, JP, and ACS.
  • Operational knowledge with the following analytical instruments, Karl Fisher Titrator, Polarimeter, Osmometer, UV-Vis Spectrometer, FTIR, Near IR, Gas Chromatography, UPLC, and HPLC.
  • Previous experience with method transfer desired.
  • Experience with LIMS and Smart lab computer applications a plus.
  • Ability to lead a dynamic work force.
  • Proficient in common computer software applications.
  • Strong general laboratory and organizational skills, effective communication skills, both oral and written.

Company

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.

We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.

We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.

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Company info
Website
Phone
+1-800-332-2056
Location
430 E. 29th St
14th Floor
 New York
New York
10016
United States
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