Biotech Manufacturing Associate I/II – Aseptic GMP

Kashiv BioSciences, LLC; Chicago (IL); On-site; USD 50,000 - 71,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Benefits

401K

Free Parking

Transit Access

Job summary

Kashiv BioSciences, LLC in Chicago, IL, is seeking a Manufacturing Associate I/II to support biotech product manufacturing for clinical and commercial use. The role requires aseptic technique, adherence to cGMP and SOPs, and operation of sterilization and filling equipment in controlled cleanroom environments.

Responsibilities include line clearance, material weighing, equipment operation, in-process testing, and maintaining documentation.

Qualifications

• Associate degree or higher in Biology, Chemistry, Biotechnology, Pharmacy, or related preferred.
• 1–4 years of industry experience in biologics manufacturing.
• Autoclave, filling machine operation, aseptic techniques, and clean room manufacturing experience preferred.

Responsibilities

• Take line inspection/line clearance in ISO6, ISO7, and ISO8 areas.
• Weigh and dispense materials.
• Operate autoclave, filter, and mixing system.
• Operate syringe filler and non-viable particle counter.
• Calibrate pH and conductivity meters and weighing scales.
• Standardize and operate peristaltic pump.
• Perform filter integrity tests.
• Involve in formulation and filtration of drug product.
• Involve in aseptic filling activities with proper aseptic practices.
• Maintain clean ISO5/ISO6 areas per SOP.
• Manage inventory of consumables.
• Verify raw materials and other materials.
• Assemble, clean, sterilize, and operate equipment.
• Prepare media and buffer solutions.
• Submit samples and in-process testing data (pH, conductivity, etc.).
• Record process steps electronically when required.
• Complete batch records and cGMP documentation accurately.
• Remove and dispose of soiled/expired materials.
• Ensure clean room manufacturing conditions.
• Report nonconformances to supervisor.
• Assist in tech transfer from Process Development to cGMP manufacturing.
• Comply with safety, cGMP and company policies.
• Perform other functions (Packaging) as required.

Skills

Aseptic techniques

cGMP compliance

SOP adherence

Equipment operation

English communication

Problem solving

Teamwork

Education

Associate degree or higher in Biology, Chemistry, Biotechnology, Pharmacy, or related

Tools

POMS

LIMS

SAP

NetSuite

Job description

Kashiv BioSciences, LLC in Chicago, IL, is seeking a Manufacturing Associate I/II to support biotech product manufacturing for clinical and commercial use. The role requires aseptic technique, adherence to cGMP and SOPs, and operation of sterilization and filling equipment in controlled cleanroom environments.

Responsibilities include line clearance, material weighing, equipment operation, in-process testing, and maintaining documentation.