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Sr. Scientist
Investigations
Posted on 7/6/2022
INACTIVE
Locations
Summit, NJ, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
React.js
Writing
Requirements
  • Advanced working experience of deviation investigations utilizing root cause analysis tools
  • Working experience in the CAPA process and ability to identify and verify effectiveness
  • Working experience in the change management and associated change control processes
  • Advanced technical writing skills and ability to collaborate effectively in cross functional teams
  • Proven ability to accurately and completely understand, follow, interpret, apply Global Regulatory and cGMP requirements
  • Experience supporting health authority inspections
  • Knowledge of data trending and tracking, including use of statistical analysis software
  • Demonstrate advanced problem-solving ability / mentality, technical adeptness and logical thinking
  • Ability to set priorities, manage timelines and effectively react/manage changing priorities
  • Ability to work with management (global and site) and support corporate and departmental goals
  • Ability to communicate honestly, transparently and effectively with peers, department management and cross functional peers
  • Ability to utilize electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory Management system)
  • Hands on experience preferred with various analytical techniques such as ELISA, qPCR, Cell Concentration, Sterility, Mycoplasma, Endotoxin, flow cytometry, and Environmental Monitoring
  • Hands on experience preferred with Manufacturing Environmental Monitoring programs, which includes viable and non-viable air particulates, surface sampling and personnel monitoring
  • Knowledge of Manufacturing class designation, such as Class D, Class C and Class A
  • Strong understanding of Contamination Control, such as air flow, movement of materials and personnel
  • Ability to mentor junior associates to foster and develop their expertise
  • Requires a Bachelor's Degree in science, preferably in Biochemistry, Immunology, Molecular and Cellular Biology, Biology, Microbiology or related discipline (advanced degree preferred)
  • 5+ years of relevant work experience, preferably in a health authority regulated environment
  • Previous experience in a gene or cell therapy facility is preferred (CAR-T a plus)
  • An equivalent combination of education and experience may substitute
Responsibilities
  • Conduct thorough investigations (OOS, OOT, Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools
  • Perform GEMBA walks with stakeholders to better understand process steps, and evaluate the need to make process improvements, with the coordination of Subject Matter Experts
  • Identify effective CAPAs, develop CAPA plans and assure CAPA effectiveness
  • Assess potential impact and risk to product or process associated changes may have upon change implementation and develop an appropriate mitigation strategy
  • Initiate change control documentation and assist other QC functional groups with change management documentation
  • Identify functional area SMEs to perform impact assessments as part of the change management process
  • Ensure all investigations, CAPAs and change controls are completed in a timely manner. Notify stakeholders of any delays in a timely manner
  • Provide technical support for manufacturing investigations / CAPAs / change controls as needed
  • Support QC during audits and site inspections for QC compliance related inquiries
  • Handle complex issues and solve problems with minimal guidance
  • Provide mentorship, guidance and training to junior members
  • Serve as author or technical reviewer of departmental procedures as appropriate
  • Support manufacturing and Quality Control testing of CAR-T products as needed
  • Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems
  • Continuously support QC, living the “patients first” mission and fostering a “Right First Time” mindset
Bristol-Myers Squibb

10,001+ employees

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