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 a Biologics Upstream Manufacturing Associate to support cell culture operations in a cGMP environment. The ideal candidate will have hands-on bioprocessing experience and a strong understanding of bioreactor operations. Responsibilities include executing upstream processes, troubleshooting equipment, and ensuring compliance with safety and quality standards.

Qualifications

• Minimum of 3 years' experience in upstream biologics manufacturing.
• Proficiency in aseptic techniques and single-use technologies.

Responsibilities

• Perform upstream manufacturing activities including cell culture and bioreactor operations.
• Collaborate with engineering and quality teams for batch readiness.
• Document batch execution and deviations accurately.

Skills

Attention to Detail

Teamwork

Aseptic Techniques

Documentation Skills

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

Biologics Upstream Manufacturing Associate

Support cell culture operations in a fast-paced, cGMP biopharmaceutical environment focused on mammalian-based biosimilar production. Execute upstream processes for engineering and clinical-scale batches ranging from 50 L to 1000 L.

Key Responsibilities:

• Perform upstream manufacturing activities including cell culture and bioreactor operations at various scales.
• Support production of engineering and clinical batches in compliance with cGMP standards.
• Operate and troubleshoot bioreactors, single-use systems, and related equipment.
• Collaborate with engineering and quality teams to ensure batch readiness and execution.
• Document batch execution, deviations, and investigations accurately.
• Review batch records and supporting documentation.
• Follow safety procedures and maintain compliance with environmental, health, and safety policies.
• Participate in continuous improvement initiatives for manufacturing processes and equipment.

Requirements:

• Bachelor's or Master's degree in Biochemistry, Chemical Engineering, Biology, or related field.
• Minimum of 3 years' experience in upstream biologics manufacturing in a cGMP environment.
• Proficiency in aseptic techniques and single-use technologies.
• Strong understanding of cell culture processes and bioreactor operations.
• Experience with GMP documentation including batch records and protocols.
• Ability to work independently and as part of a team.
• Attention to detail, strong documentation skills, and basic computer proficiency.

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