Biologics Manufacturing Expert

1 month ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time
Job Summary

We are seeking an experienced Biologics Manufacturing Expert in Quality Assurance to join our team at AGC Biologics. This role will be responsible for supporting Supply Chain, Process Transfer, and QC for late-stage and commercial products.

Key Responsibilities
  • Close collaboration with internal stakeholders to ensure effective quality-related activities.
  • Change control, deviation handling, and CAPAs to maintain compliance with cGMP.
  • Review and approval of material specifications to guarantee product quality.
  • Release of raw materials and disposables to support manufacturing operations.
Requirements
  • 3+ years of experience in Quality Assurance and/or Material Management.
  • A relevant academic background in pharmacy, biotechnology, biology, chemistry, or a similar field.
  • Proven experience in QA and/or Material Management, including oversight and guidance of staff.
  • Experience with contract manufacturing and business understanding.
  • Deviation handling, including root cause investigations, and review and evaluation of cGMP documentation.
About the Company

AGC Biologics is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy, and the USA. We provide comprehensive commercial and clinical cGMP biologics manufacturing services from DNA to active pharmaceutical ingredient (API).

What We Offer

We offer a dynamic working environment with opportunities for professional growth and development. Our company culture values collaboration, innovation, and customer satisfaction. The successful candidate will have a competitive salary range of $85,000 - $110,000 per annum, depending on experience.



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