Biologics Upstream Manufacturing Associate

Pharma Universe; New York (NY); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading biopharmaceutical company is seeking an Upstream Manufacturing Associate in New Jersey. This full-time role involves hands-on execution of upstream processes in a cGMP environment, focusing on mammalian-based biosimilar production. Ideal candidates will have a strong background in bioprocessing and a commitment to quality and safety standards.

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.
• Collaborate with cross-functional teams to ensure batch readiness.

Skills

Aseptic Technique

Attention to Detail

Documentation Skills

Education

Bachelor's or Master's degree in Biochemistry

Chemical Engineering

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.