Kashiv BioSciences is a fully integrated biosciences company with an expanded and dynamic platform for growth including advanced drug delivery technologies, biosimilars, prodrugs, and a large development pipeline. We are looking for an experienced Microbiologist to join our Piscataway, NJ Quality Management team.This is an exciting opportunity to work closely with Management on all aspects of QC Microbiology related to our pharmaceutical manufacturing site. Will work as a member of the Quality team on Microbiology testing to ensure quality standards.
RESPONSIBILITIESCoordinates microbiological testing, release of product and testing for validation protocolsPerforms organism identification.Performs technical review of batch filling records to ensure quality of aseptic processes.Reads and interprets microbiological cultures and other related tests including but not limited to environmental monitoring, Endotoxin, growth promotion, microbial limits tests.May perform validation, technology transfer and troubleshooting, and write policy procedure for quality initiatives.Reviews and approves environmental monitoring data and laboratory equipment and records. Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness.Performs other functions as required or assignedComplies with all company policies and standards
Other special projects and/or duties may be assigned by Management.Trains other Microbiologist on Department methods, process and procedure.Works with other departments to accomplish Company goals or projects.Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure Ability to write routine reports and/or correspondence.Ability to speak effectively before groups or employees of organization.Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule
BS or MS in a scientific discipline or equivalent and a minimum 3-8 years related experience.
Expert knowledge of scientific principles and concepts.