Sr. Scientist - Microbiology

Celltrion Branchburg, LLCBranchburg Township, NJ
Hybrid

About The Position

This position relies on experience and knowledge in the field of Microbiology to perform work in a compliant manner. Conducts routine of microbiological samples. Perform non-routine analyses as assigned by supervisor as needed. Creates and/or revising technical documents, creating and/or leading special microbiological projects, and training new/existing employees on procedures and job functions. Uses scientific expertise to provide assistance to coworkers for troubleshooting, laboratory investigations and problems resolution. Suggests process improvements to QC management. Maintains familiarity in a variety of microbiological concepts, practices, and procedures. Performs routine QC responsibilities as needed. Applies acceptable cGMP practices and ALCOA principles during execution of all work tasks. Presents innovative and creative solutions to problems. Exhibits good problem solving and technical writing skills. Updates supervisor of progress on a regular basis.

Requirements

  • Excellent teamwork and communication skills
  • Great attention to detail
  • Ability to work independently and achieve problem resolution with minimal supervision
  • Competent in use of Microsoft Office programs
  • Comfortable with computerized data storage systems (i.e. MODA, LIMS, SmartLab, TrackWise, etc)
  • Good working knowledge of cGMP regulations

Nice To Haves

  • Flexibility to work weekends, overtime, and holidays as needed

Responsibilities

  • Perform routine microbiological testing on water, gas, in-process materials, final products, raw materials, environmental/water samples, finished goods
  • Performs material qualifications and QC inventory control
  • Performs identification of organisms
  • Performs Bioburden, Endotoxin, Sterility, Microbial Identification, and biological indicator testing
  • Prepares and maintains microbial stock culture
  • Performs method suitability (bacteriostasis/fungi stasis) testing
  • Assists in special projects (i.e. validations, microbiological studies, etc)
  • Creates, revises, or reviews documents such as SOPs, material specifications, protocols, and trend reports (water, environmental monitoring, or invalid assays)
  • Performs analytical and deviations investigations
  • Reviews microbiology testing data and logbooks
  • Train other analysts on procedures, as needed
  • Ensuring that laboratory equipment is maintained and within calibration

Benefits

  • paid time off (holidays, vacation, and additional leave)
  • medical, dental, and vision insurance
  • life insurance
  • a company-matched retirement savings plan
  • wellness programs
  • short- and long-term disability benefits
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