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 execute and work closely with Management on all aspects of Microbiology related to our pharmaceutical manufacturing site.
Reads, interprets microbiological cultures and other related tests including but not limited to environmental monitoring, Endotoxin, growth promotion, microbial limits tests.
Prepare protocol and perform product suitability/method validation of endotoxin and bio-burden
Perform environmental monitoring in clean room
Perform Endotoxin, growth promotion, microbial limits tests.
Able to perform Purified and WFI microbial analysis test
Performs organism identification.
Other Microbiological testing, release of product and testing for validation protocols
Maintain the microbial sample inward register.
Performs technical review of batch filling records to ensure quality of aseptic processes.
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 microbiological / quality functions as required or assigned by supervisor
Complies with all company policies and standards
Can carry EM instruments and travel 5 miles to perform EM monitoring
BS or MS / Microbiologist in a scientific discipline or equivalent and a minimum 6 years of related experience.
Expert knowledge of scientific principles and concepts.
Must be able to preform endotoxin, bioburden and product suitability testing.
Trains other Microbiologists on department methods, process and procedure.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Effective verbal and written communication and reporting writing skills
Work Environment & Physical Demands:
General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. Some travel may be involved.
This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.
Kashiv BioSciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Kashiv BioSciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.