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Albumin Production Specialist
2 weeks ago
We are seeking an expert in albumin and immunoglobulin production to join our team as a consultant. This is a unique opportunity to shape and lead a cutting-edge biologics manufacturing program with long-term impact.
About the Role- Design and scale manufacturing processes for albumin and immunoglobulins.
- Advise on technology selection, facility setup, and equipment procurement.
- Ensure compliance with current good manufacturing practices (cGMP), FDA, EMA, DCGI, ICH, and WHO guidelines.
- Support regulatory filings (IND, BLA, DMF, etc.) and strengthen legal/regulatory compliance.
- Implement quality assurance and quality control systems.
- Mentor and train internal teams to build long-term organisational expertise.
- Advanced degree (M.Sc./PhD in biotechnology, biochemistry, or related field).
- 10+ years' experience in biologics manufacturing, with specific expertise in albumin and immunoglobulins.
- Proven track record in large-scale plasma fractionation or recombinant protein production.
- In-depth knowledge of regulatory frameworks (FDA, EMA, DCGI, ICH, WHO).
- Strong leadership qualities with potential to scale into a director role.
