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Senior Manager – Principal Scientist
Analytical Science & Technology, Cell Therapy Quality
Posted on 8/11/2022
INACTIVE
Locations
Seattle, WA, USA • Summit, NJ, USA • Devens, MA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
Writing
Requirements
  • MS/PhD in relevant scientific discipline and 10+ years (or equivalent combination) experience in multi-parameter (>10-color) flow cytometry execution, training, and technical support. Experience in cellular therapies is preferred
  • Strong scientific background and expertise with multiple flow cytometry platforms from analyzers to cell sorters
  • Experience in analytical method lifecycle, including method transfer, validation and maintenance. Experience providing training in method execution as well as instrument operation and standardization. Experience with implementing flow cytometry methods in a commercial QC facility is preferred
  • Experience in cGMP regulations and application within the Quality Control environment. Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of biological products
  • Must possess effective time management skills, demonstrate initiative, resourcefulness and flexibility to work independently and as part of a team
  • Strong technical writing experience (SOPs, Method Validation Protocols and Reports) is essential
Responsibilities
  • Responsible for the stewardship of late-phase flow cytometry methods in the Quality organization
  • Implement method lifecycle and method maintenance programs to support flow cytometry methods used in the release of cell therapy drug products
  • Responsible for transfer and validation of methods from Development to Quality Control (QC) laboratories in compliance with global regulatory requirements
  • Responsible for authoring relevant analytical sections of submissions, responding to health authority questions and representing the QC function during inspections
  • Function as the flow cytometry technical expert for QC labs during internal QC investigations and as the Quality liaison with contract test labs during QC investigations
  • Partner with development organizations in the design of development and qualification studies, selection and characterization of reagents, and method optimization initiatives. Represent the QC department on cross-functional project development teams
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.