Biologics Upstream Manufacturing Associate

Pharma Universe; Piscataway Township (NJ); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading biopharmaceutical company is seeking an Upstream Manufacturing Associate to support cell culture operations in a cGMP environment. This role involves executing upstream processes for engineering and clinical-scale batches, ensuring compliance with industry standards. Ideal candidates will have a strong background in bioprocessing and a commitment to safety and quality.

Benefits

Relocation support offered for US Citizens

Qualifications

• Minimum 3 years' experience in upstream biologics manufacturing in a cGMP environment.
• Proficiency in aseptic technique and working with single-use technologies.

Responsibilities

• Execute upstream manufacturing activities including cell culture and bioreactor operations.
• Support production of engineering and clinical batches in compliance with cGMP standards.

Skills

Aseptic Technique

Attention to Detail

Team Collaboration

Education

Bachelor's or Master's degree in Biochemistry

Bachelor's or Master's degree in Chemical Engineering

Bachelor's or Master's degree in Biology

Job description

Upstream Manufacturing Associate - Biologics - cGMP Environment (Full-Time, Onsite - New Jersey, USA)

• Relocation support offered for US Citizens*
  
  

Upstream Manufacturing Associate to support cell culture operations in a fast-paced, cGMP biopharmaceutical environment focused on mammalian-based biosimilar production. This role involves hands-on execution of upstream processes for engineering and clinical-scale batches ranging from 50 L to 1000 L.

Key Responsibilities:

• Execute upstream manufacturing activities including cell culture and bioreactor operations at various scales
• Support the production of engineering and clinical batches in compliance with cGMP standards
• Operate and troubleshoot bioreactors, single-use systems, and associated upstream equipment
• Collaborate with cross-functional teams including engineering and quality to ensure batch readiness and execution
• Accurately document batch execution, deviations, and investigations as required
• Assist in reviewing executed batch records and supporting documentation
• Follow all safety procedures and maintain compliance with environmental, health, and safety policies
• Contribute to continuous improvement initiatives in manufacturing processes and equipment operation
  
  
  

Requirements:

• Bachelor's or Master's degree in Biochemistry, Chemical Engineering, Biology, or related field
• Minimum 3 years' experience in upstream biologics manufacturing in a cGMP environment
• Proficiency in aseptic technique and working with single-use technologies (bags, tubing, manifolds, etc.)
• Strong understanding of cell culture processes and bioreactor operations
• Experience initiating and executing GMP documentation including batch records and protocols
• Comfortable working independently with minimal supervision while contributing to a team-based environment
• Strong attention to detail, written documentation skills, and basic computer proficiency (Word, Excel, etc.)
  
  

This role is ideal for candidates with hands-on bioprocessing experience who are confident operating in a clinical and GMP-regulated setting.