Manufacturing Associate I, Upstream Processing (3rd shift)

System One; Pennington (NJ); Presencial; USD 30 000 - 34 000; Tempo integral

Resumo da oferta

System One seeks a Manufacturing Associate I, Upstream Processing, for a 3rd shift in Pennington, NJ. The role involves supporting day-to-day upstream bioprocessing in a cGMP environment, including media prep, seed train expansion, bioreactor operations, harvests, and aseptic processing.

Candidates with biology/biotech backgrounds and familiarity with SOPs and GMP documentation will thrive in a collaborative, quality-driven team.

Qualificações

• Experience or academic exposure to cell culture, bioprocessing, or biological manufacturing.
• Experience with cell culture operations, shake flasks, bioreactors, media and buffer preparation, or aseptic processing.
• Strong attention to detail and documentation practices.
• Ability to follow SOPs and work effectively in a team; cGMP knowledge preferred.

Responsabilidades

• Prepare media and buffers following batch records and SOPs.
• Support cell culture operations, including seed train expansion, bioreactor processes, and harvest activities.
• Perform equipment setup, cleaning, sanitization, and basic maintenance.
• Execute manufacturing activities in a cGMP cleanroom using aseptic techniques.
• Complete batch records and GMP documentation accurately.
• Report deviations, equipment issues, and operational concerns.
• Participate in training and continuous improvement initiatives.

Conhecimentos

Cell culture operations

Shake flask cultivation

Bioreactor systems

Media and buffer preparation

Aseptic processing

SOP adherence

Formação académica

Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or related field

High School Diploma/GED with 4+ years biopharmaceutical manufacturing

Descrição da oferta de emprego

Job Title

Manufacturing Associate I, Upstream Processing (3rd Shift)

Location

Pennington, NJ 08534

Shift

Monday-Friday, 10:00 PM - 6:00 AM

Pay Rate

$22.00 - $25.00 per hour (Based on Experience), Shift Differential +$3/hour

Industry

Global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO) and Biosimilar Developer

Position Overview

The Upstream Manufacturing Associate I is responsible for supporting day-to-day upstream manufacturing operations within a cGMP cleanroom environment. This role assists with 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 and company procedures.

Key Responsibilities

• Prepare media and buffers following batch records and SOPs.
• Support cell culture operations, including seed train expansion, bioreactor processes, and harvest activities.
• Perform equipment setup, cleaning, sanitization, and basic maintenance.
• Execute manufacturing activities in a cGMP cleanroom using aseptic techniques.
• Complete batch records and GMP documentation accurately.
• Report deviations, equipment issues, and operational concerns.
• Participate in training and continuous improvement initiatives.

Qualifications

• Experience or academic exposure to cell culture, bioprocessing, or biological manufacturing.
• Experience with one or more of the following:
  • Cell culture operations
  • Shake flask cultivation
  • Bioreactor systems
  • Media and buffer preparation
  • Single-use technologies
  • Aseptic processing
• Strong attention to detail and documentation practices.
• Ability to follow SOPs and work effectively in a team environment.
• Knowledge of cGMP regulations preferred.
• Ability to work in a cleanroom environment while wearing required PPE.
• Ability to stand for extended periods and lift up to 25 pounds.
• Education & Experience
  • Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related field with 0-2 years of relevant experience; OR
  • High School Diploma/GED with 4+ years of relevant biopharmaceutical manufacturing experience.

Why Join This Position?

This is an excellent opportunity for recent life science graduates and early-career biopharmaceutical professionals looking to gain hands‑on experience in upstream manufacturing within a GMP-regulated environment. Join a collaborative team focused on quality, innovation, and continuous improvement while building a strong foundation in biologics manufacturing with a growing global CDMO and biosimilars organization.

Key Skills:

Biotechnology, Biochemistry, Life Sciences, Biologics Manufacturing, Biopharmaceutical Production, Manufacturing Associate, Upstream Processing, Cell Culture Technician, Bioprocess Technician, GMP Manufacturing, Cleanroom Technician, Biotech Manufacturing, Process Associate, Biomanufacturing, Bioreactor Technician, Aseptic Manufacturing, Protein Production, Biosimilars, CDMO, Pharmaceutical Manufacturing.

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