Biologics 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 to support cell culture operations in a cGMP environment. The role involves executing upstream processes for engineering and clinical-scale batches, ensuring compliance with cGMP standards, and collaborating with cross-functional teams. Ideal candidates will have hands-on bioprocessing experience and a strong understanding of cell culture processes.

Benefits

Relocation support offered for US Citizens

Qualifications

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

Responsibilities

• Execute upstream manufacturing activities including cell culture and bioreactor operations.
• Document batch execution, deviations, and investigations as required.

Skills

Aseptic Technique

Attention to Detail

Team Collaboration

Education

Bachelor's or Master's in Biochemistry

Tools

Word

Excel

Job description

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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.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Manufacturing

• Industries

  IT Services and IT Consulting

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