Biologics Manufacturing Associate

Pharma Universe; New York (NY); On-site; USD 70,000 - 100,000; Full time

Job summary

Eine dynamische Firma in der biopharmazeutischen Industrie sucht einen Upstream Manufacturing Associate, um Zellkulturoperationen in einem schnelllebigen, cGMP-Umfeld zu unterstützen. In dieser Rolle sind Sie verantwortlich für die Ausführung von upstream Prozessen für klinische und ingenieurtechnische Chargen. Sie arbeiten eng mit funktionsübergreifenden Teams zusammen und tragen zur kontinuierlichen Verbesserung der Herstellungsprozesse bei. Wenn Sie über praktische Erfahrung in der Bioprozessierung verfügen und in einem regulierten Umfeld sicher arbeiten können, ist dies die perfekte Gelegenheit für Sie, Ihre Karriere voranzutreiben.

Benefits

Umzugshilfe für US-Bürger

Qualifications

• 3+ Jahre Erfahrung in der upstream Biologics-Herstellung in einer cGMP-Umgebung.
• Kenntnisse in aseptischer Technik und Bioreaktoroperationen.

Responsibilities

• Durchführung von upstream Herstellungsaktivitäten einschließlich Zellkultur und Bioreaktoroperationen.
• Dokumentation der Batch-Ausführung und Unterstützung bei GMP-Dokumentation.

Skills

Aseptische Technik

Zellkulturprozesse

Bioreaktoroperationen

GMP-Dokumentation

Detailgenauigkeit

Education

Bachelor in Biochemie

Master in Chemieingenieurwesen

Tools

Bioreaktoren

Einweg-Technologien

Microsoft Word

Microsoft 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.