Upstream Manufacturing Associate I

CONTRACT: 6 month contract to start with the potential to extend and convert to full-time

Shifts available:

• 2nd shift: 2pm-10pm
• 3rd shift: 10pm-6am

MUST HAVES:

• Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline with 0-2 years of relevant experience

Position Overview

The Upstream Manufacturing Associate I provides support for upstream manufacturing activities within a cGMP environment.

Key Responsibilities

Upstream Processing

• Perform cell culture activities including vial thaw, seed train expansion, fed-batch and perfusion bioreactor operations.
• Oversee harvest and filtration operations.
• Monitor critical process parameters and implement corrective actions when required.
• Troubleshoot process and equipment issues to ensure uninterrupted operations.

In-Process Testing

Perform and review manufacturing support testing utilizing:

• Cedex Cell Analyzer
• Blood Gas Analyzer (BGA)
• Osmometer
• Other process monitoring equipment

Documentation & Compliance

• Assist with preparation and revision of: Standard Operating Procedures (SOPs), Master Batch Records (MBRs), and Manufacturing forms/templates
• Support deviation investigations, CAPAs, and change controls.
• Ensure ongoing inspection readiness and GMP compliance.
• Participate directly in regulatory and client audits.

Cross-Functional Coordination

• Coordinate activities between Manufacturing, QA, QC, MSAT, Warehouse, Facilities, and Supply Chain teams.
• Support process validation, technology transfer, and commercial manufacturing initiatives.
• Drive continuous improvement and operational excellence projects.

Qualifications

Education & Experience

• Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline with 0-2 years of relevant experience.
• High School Diploma/GED with 4 years of relevant biopharmaceutical manufacturing experience may be considered.

Required Skills

• Basic understanding of biological manufacturing and cell culture processes.
• Ability to follow detailed instructions and procedures.
• Strong attention to detail and documentation practices.
• Effective communication and teamwork skills.
• Knowledge of cGMP requirements is preferred.

Preferred Skills

Experience with:

• Cell culture operations
• Shake flask cultivation
• Bioreactor systems
• Buffer and media preparation
• Single-use technologies
• Aseptic processing

Physical Requirements

• Ability to stand for extended periods.
• Ability to bend, reach, and lift up to 50 pounds.
• Ability to work in cleanroom environments while wearing required PPE.