Upstream Manufacturing Associate

Pharma Universe; Pennsylvania Furnace (PA); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking an Upstream Manufacturing Associate to join their dynamic team in a fast-paced biopharmaceutical environment. This role focuses on supporting cell culture operations for mammalian-based biosimilar production, where you'll execute upstream processes for engineering and clinical-scale batches. Ideal candidates will have hands-on bioprocessing experience and thrive in a cGMP-regulated setting, ensuring compliance and quality throughout the manufacturing process. If you're passionate about biopharmaceuticals and eager to contribute to innovative production techniques, this opportunity is perfect for you.

Benefits

Relocation Support

Health Insurance

401(k) Plan

Paid Time Off

Professional Development Opportunities

Qualifications

• 3+ years of experience in upstream biologics manufacturing in a cGMP environment.
• Proficiency in aseptic technique and strong understanding of cell culture processes.

Responsibilities

• Execute upstream manufacturing activities including cell culture and bioreactor operations.
• Collaborate with cross-functional teams to ensure batch readiness and execution.

Skills

Aseptic Technique

Cell Culture Processes

Bioreactor Operations

GMP Documentation

Education

Bachelor's Degree in Biochemistry

Master's Degree in Chemical Engineering

Tools

Single-Use Technologies

Bioreactors

Word Processing Software (Word, Excel)

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.