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Manager – QC Analytical
Posted on 8/31/2022
INACTIVE
Locations
Devens, MA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
SAP
PowerPoint/Keynote/Slides
Excel/Numbers/Sheets
Requirements
  • Experience with various bioanalytical techniques (cell based assays, ELISA, qPCR, flow cytometry) and associated equipment
  • Experience with laboratory LIMS, ELN, and ERP systems (e.g., SAP) preferred
  • Ability to work in a highly regulated environment and follow regulatory requirements and GMPs
  • Ability to mentor associates, manage multiple assignments while meeting timelines in a GMP environment
  • Advanced ability to work collaboratively in a high-paced team environment, meet deadlines, and prioritize work from multiple projects
  • Excellent organizational and critical thinking skills
  • Advanced problem-solving ability/mentality, technically adept and logical
  • Advanced ability to communicate effectively with peers, department management and cross-functional peers
  • Proficient with Excel, Visio, PowerPoint, and other common software applications
  • Bachelor's degree required, preferably in Chemistry, Microbiology or related science
  • 6+ years of relevant laboratory work experience, preferably in a regulated environment
  • 2+ years of management and people leader experience
  • An equivalent combination of education and experience may substitute
Responsibilities
  • Supervise the QC Analytical lab staff on shift and oversee the daily lab activities related to in-process, final release, and stability testing of cell therapy drug product
  • Develop and execute a work plan for the shift, ensuring safety, quality, and performance targets are achieved
  • Perform QC data review ensuring results are compliant with specifications and regulations. Report abnormalities
  • Track, trend, and report key performance metrics. Drive continuous improvement in the lab to increase productivity and efficiency. May collaborate with other departments to identify and implement process improvements
  • Review and approve test methods and procedures to ensure operational alignment and compliance with corporate policies and procedures
  • Own and evaluate relevant change controls, investigations, deviations, CAPAs
  • Hire, mentor, and develop team members to support the business operations and employee career development
  • Oversee training of the team members
  • Communicate effectively with management regarding task completion, roadblocks, and needs
  • Responsible for cGMP compliance in all aspects of laboratory operations. Participate in site team supporting and managing regulatory inspections and findings
  • Perform other tasks as assigned
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.