Upstream Manufacturing Associate

Pharma Universe; New York (NY); On-site; USD 60,000 - 100,000; Full time

Job summary

Ein innovatives Unternehmen in der Biopharmazeutik sucht einen engagierten Upstream Manufacturing Associate, um die Zellkulturoperationen in einem dynamischen, cGMP-regulierten Umfeld zu unterstützen. Diese spannende Rolle bietet die Möglichkeit, an der Produktion von biosimilaren Produkten in verschiedenen Maßstäben zu arbeiten. Sie werden aktiv an der Durchführung und Dokumentation von Herstellungsprozessen beteiligt sein und mit funktionsübergreifenden Teams zusammenarbeiten, um die Einhaltung der cGMP-Standards sicherzustellen. Wenn Sie Erfahrung in der biopharmazeutischen Herstellung haben und in einem schnelllebigen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Benefits

Umzugshilfe für US-Bürger

Qualifications

• 3+ Jahre Erfahrung in der upstream Biologika-Herstellung in einer cGMP-Umgebung.
• Starke Kenntnisse in Zellkulturprozessen und Bioreaktoroperationen.

Responsibilities

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

Skills

Aseptische Technik

Bioreaktor-Betrieb

Dokumentation von GMP

Zellkulturprozesse

Education

Bachelor in Biochemie

Master in Biochemie

Tools

Einwegtechnologien

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.