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Senior Specialist
QC Analytical, B2 shift, Cell Therapy
Posted on 7/27/2022
INACTIVE
Locations
Devens, MA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Data Analysis
Management
Writing
Requirements
  • Bachelor's degree required, preferably in Science. Advanced degree preferred
  • 4+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment
  • Hands on experience with various bioanalytical techniques (cell based assays, flow cytometry, ELISA, qPCR) and scientific knowledge in the characterization, validation and transfer of bioanalytical methods
  • Demonstrated experience working with polychromatic flow cytometry panels and flow cytometry data analysis
  • 3+ years of experience in multi-parameter (>8-color) flow cytometry execution, training, and technical support. Experience in cellular therapies is preferred
  • Strong technical background and expertise with multiple flow cytometry platforms preferred, including BD Biosciences platforms
  • Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements
  • Strong technical writing skills
  • Strong problem-solving ability/mentality, technically adept and logical
  • Ability to represent the interests of the group on cross-functional teams
  • Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work
  • Strong ability to communicate effectively with peers, department management and cross-functional peers. Ability to work with management locally and globally
  • Working knowledge of LIMS
Responsibilities
  • Perform method transfer/validation and routine testing of in-process, final product, and stability samples
  • Use scientific principles to assist with analytical testing methods and the proper use of laboratory equipment
  • Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner
  • Review all data in accordance with applicable procedures and cGMP requirements
  • Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs
  • Train new analysts to general job duties
  • Become a qualified trainer on assigned assays and deliver training to analysts, documenting training per procedural and cGMP requirements
  • Support document revision, project, CAPA, and investigation/deviation related tasks
  • Perform assigned tasks within a CAPA, deviation, or project
  • May lead projects and continuous improvement efforts
  • Perform other tasks as assigned
  • Support for QC and manufacturing operations requires shift coverage consisting of weekdays, weekends, holidays, and during adverse weather conditions. This position works the following shift schedule:
  • PM Shift: Wednesday to Saturday 2 PM - 12 AM
Desired Qualifications
  • FCS Express software experience is a plus
Bristol-Myers Squibb

10,001+ employees

Biopharmaceutical development company
Company Overview
Bristol-Myers Squibb engages in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceuticals.