Upstream Manufacturing Associate

Upstream Manufacturing Associate I, II or II (depending on experience)

Location: 100% onsite in Pennington, NJ

Duration: 6 month contract, potential for extension or conversion

Schedule: 1st, 2nd, 3rd shift

These positions require a lot of flexibility – may require OT, evening work, overnight work, weekends, & holidays.

Position Overview

The Upstream Manufacturing Associate I is responsible for executing day-to-day upstream manufacturing operations in a cGMP cleanroom environment. This position supports cell culture manufacturing activities including media and buffer preparation, seed train expansion, bioreactor operations, harvest processing, equipment cleaning, and aseptic processing while ensuring compliance with GMP requirements.

Key Responsibilities

Upstream Manufacturing Operations

• Prepare media and buffers according to approved procedures and batch records.

• Perform vial thaw, shake flask culture, seed train expansion, and bioreactor support activities.

• Support fed-batch and perfusion bioreactor operations.

• Execute harvest and filtration activities.

• Perform equipment setup, cleaning, sanitization, and routine maintenance activities.

Aseptic Processing

• Perform manufacturing activities within classified cleanroom environments.

• Adhere to aseptic techniques and contamination control procedures.

• Follow gowning and cleanroom behavior requirements.

Documentation & Compliance

• Complete batch records, logbooks, and associated GMP documentation accurately and contemporaneously.

• Follow SOPs, batch records, and work instructions.

• Report deviations, equipment issues, and atypical events to supervision.

• Support internal audits and inspection readiness activities.

Continuous Improvement

• Participate in training programs and qualification activities.

• Support process improvement initiatives 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:

o Cell culture operations

o Shake flask cultivation

o Bioreactor systems

o Buffer and media preparation

o Single-use technologies

o 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.