JOB DETAILS

Microbiology Manager

CompanyKashiv BioSciences, LLC
LocationChicago
Work ModeOn Site
PostedMay 16, 2026
About The Company
Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets and is among the few U.S.-based companies to both manufacture and receive marketing authorization for multiple biosimilars. Kashiv BioSciences, LLC in the USA, and its subsidiaries in India (together “Kashiv BioSciences”) operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.
About the Role

Description

  

Position Summary

The Microbiology Manager works closely with the Director on department strategy and work projects. Fills in as Microbiologist Subject Matter Expert (SME) as needed. Supervises, schedules and executes on microbiological testing, release of product and testing for validation protocols.


Essential Duties & Responsibilities

  • Supervises and coordinates microbiological testing, release of product and testing for validation protocols.
  • Performs 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, sterility tests, 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 assigned
  • Complies with all company policies and standards

Requirements

  

Position Requirements and Qualifications

  • BS or MS in a scientific discipline or equivalent and a minimum 5-10 years related experience. 


Special Skills:

  • Expert knowledge of scientific principles and concepts.
  • 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 manuals.
  • 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 form.

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.


Supervisory Responsibility, if any: Yes

Key Skills
Microbiological TestingOrganism IdentificationAseptic Process ReviewEnvironmental MonitoringSterility TestingGrowth PromotionMicrobial Limits TestsValidation ProtocolsTechnology TransferTechnical WritingLaboratory Equipment ManagementSupervisory Leadership
Categories
Science & ResearchManagement & LeadershipHealthcareManufacturing
Job Information
📋Core Responsibilities
The Microbiology Manager supervises microbiological testing, product release, and validation protocols while serving as a Subject Matter Expert. They are responsible for reviewing batch records, interpreting cultures, and managing environmental monitoring data to ensure quality standards.
📋Job Type
full time
📊Experience Level
5-10
💼Company Size
561
📊Visa Sponsorship
No
💼Language
English
🏢Working Hours
40 hours
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