Manufacturing Operations Senior Associate

Job Description

We are seeking a detail-oriented Manufacturing Operations Senior Associate with experience in aseptic processing and cleanroom operations. The ideal candidate will have hands‑on experience working in Grade B cleanroom environments, executing batch processes, and maintaining accurate documentation in compliance with regulated laboratory and manufacturing standards.

Current Shift: Wednesday - Saturday 7:00am - 4:30pm (This may be updated to Tuesday-Saturday)

• Execute batch processing activities in a laboratory or manufacturing setting following established batch records and SOPs
• Follow Batch Records, SOPs, policies and all other relevant work instructions to ensure the successful and compliant operation of the drug product facility
• Perform aseptic techniques and aseptic processing in a Grade B cleanroom environment
• Prepare, process, and transfer media for cell culture operations, including filling, harvesting, filtering, and centrifugation
• Handle downstream processes such as waste removal and transfer of final product into drug product bags
• Operate and maintain equipment including peristaltic pumps, tube welders, and balances
• Accurately document all laboratory and manufacturing activities in compliance with GMP standards
• Utilize LIMS (Laboratory Information Management Systems) and MES (Manufacturing Execution Systems) for data entry, tracking, and reporting
• Ensure adherence to safety, quality, and regulatory requirements at all times

• HSD +3 years experience
• Experience working in a laboratory or biopharmaceutical manufacturing environment
• Hands‑on experience with aseptic techniques and cleanroom operations (Grade B preferred)
• Familiarity with batch record execution and GMP documentation practices
• Experience with LIMS and MES systems
• Proficiency in operating laboratory/manufacturing equipment such as peristaltic pumps, tube welders, and centrifuges
• Strong attention to detail and ability to follow precise instructions
• Good organizational and documentation skills

• Experience in cell culture processing or bioprocessing
• Prior experience in regulated environments such as pharmaceutical or biotech manufacturing

$38-$42/hr