Biologics Manufacturing Associate (Day Shift)

Takeda; Brooklyn Park (MN); On-site; USD 41,000 - 65,000; Full time

Job summary

Takeda in Brooklyn Park, MN is seeking a Manufacturing Associate I to perform daily manufacturing operations in a cGMP environment, operating bioreactors, filtration units, and chromatography systems while following SOPs.

You will handle materials, assemble and clean equipment, maintain logs, complete batch records, and enter data in SAP and LIMS, with a rotating day schedule from 5:45 AM to 6:15 PM.

Qualifications

• High school diploma or GED required; GMP experience ideal.
• Associates degree or higher in science preferred.
• Understanding of cGMP and GDP is advantageous.
• Familiarity with QC/Regulatory/QA functions beneficial.
• Experience with lab equipment helpful.

Responsibilities

• Dispense, label, and transfer raw materials and parts.
• Assemble/disassemble, clean, and sterilize components and equipment.
• Maintain equipment, area, and cleaning logs.
• Operate biologics production equipment under supervision.
• Document cGMP data in batch records and logs.
• Manage process parameters in batch records and control systems.
• Complete batch records and validation protocols.
• Review equipment use logs and perform SAP transactions.
• Enter data into LIMS and perform cleaning/sanitizing.

Skills

GMP environment

cGMP knowledge

GDP knowledge

Lab equipment experience

MS Office

Math calculations

WBT training

Documentation

Safety compliance

Education

High school diploma or GED

Associates degree or higher in science

Biotech/pharma operations knowledge

QC/Regulatory/QA knowledge

Tools

SAP

LIMS

Job description

Takeda in Brooklyn Park, MN is seeking a Manufacturing Associate I to perform daily manufacturing operations in a cGMP environment, operating bioreactors, filtration units, and chromatography systems while following SOPs.

You will handle materials, assemble and clean equipment, maintain logs, complete batch records, and enter data in SAP and LIMS, with a rotating day schedule from 5:45 AM to 6:15 PM.