Microbiologist (Micro) I, II, & III

Position Summary

Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. The company operates with robust infrastructure and highly skilled teams providing global R&D, clinical, manufacturing, regulatory, and IP capabilities. We are committed to advancing patient care and access to important medicines through our people, partners, and shared purpose.

About the Role

This individual works closely with Microbiology Management on department strategy and work projects. They coordinate microbiological testing, release of product, and testing for validation protocols. They also perform organism identification, technical review of batch filling records, and read and interpret microbiological cultures and other related tests.

Responsibilities

• 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, and microbial limits tests.
• May perform validation, technology transfer, and troubleshooting, and write policy procedures for quality initiatives.
• Reviews and approves environmental monitoring data, 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

• Previous experience for Micro I (0 to 2 years or more), Micro II (2 to 5 years or more), and Micro III (5 plus years) in a cGMP biologics/biosimilars manufacturing laboratory environment is required.
• Working knowledge of cGMP regulations (21 CFR210/211/820) is desired.
• Working knowledge of Deviation, CAPA, Change Control, and Validation/Qualification (IQ/OQ/PQ) is desired.
• Certification from professional organizations such as ASQ and ISPE is desired but not required.

Qualifications

• A 4-year Bachelor's degree, preferably in a science or engineering discipline.

Skills

• Other special projects and/or duties may be assigned by Management.
• Trains other Microbiologists on Department methods, processes, and procedures.
• 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 the organization.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Benefits

• No benefits provided.

Pay

• Micro I Specialist – Base Salary Range and Yearly Bonus (0–2 years or more of manufacturing biologics/biosimilars Quality Assurance experience): $70,000 to $75,000 (dependent on years of experience and fit for the position) with up to a 8% yearly (discretionary) cash bonus
• Micro II Specialist - Base Salary Range and Yearly Bonus (2-5 years or more of manufacturing biologics/biosimilars Quality Assurance experience): $80,000 to $85,000 (dependent on years of experience and fit for the position) with up to a 8% yearly (discretionary) cash bonus
• Micro III Specialist - Base Salary Range and Yearly Bonus (5 plus years or more of manufacturing biologics/biosimilars Quality Assurance experience): $90,000 to $95,000 (dependent on years of experience and fit for the position) with up to a 8% yearly (discretionary) cash bonus

Schedule

• No schedule provided.