Hands-On Upstream Manufacturing Associate

Pharma Universe; New York (NY); On-site; USD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a dedicated Upstream Manufacturing Associate to join their dynamic team in a fast-paced biopharmaceutical environment. This role focuses on supporting cell culture operations and executing upstream processes for biosimilar production. Ideal candidates will have hands-on experience in a cGMP setting, showcasing proficiency in bioreactor operations and adherence to strict documentation protocols. Join a company that values innovation and excellence, where your contributions will directly impact the production of life-saving biologics.

Qualifications

• 3+ years in upstream biologics manufacturing in a cGMP environment.
• Experience with GMP documentation and aseptic techniques.

Responsibilities

• Execute upstream manufacturing activities in a cGMP environment.
• Collaborate with teams to ensure batch readiness and compliance.

Skills

Aseptic Technique

Cell Culture Processes

Bioreactor Operations

GMP Documentation

Attention to Detail

Basic Computer Proficiency

Education

Bachelor's Degree in Biochemistry

Master's Degree in Chemical Engineering

Tools

Single-Use Technologies

Bioreactors

Job description

Hands-On Upstream Manufacturing Associate

Be among the first 25 applicants

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

Relocation support offered for US Citizens*

The Upstream Manufacturing Associate will 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

• Associate

Employment type

• Full-time

Job function

• Manufacturing

Industries

• Biotechnology