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4 days ago
We are seeking a highly experienced expert in albumin and immunoglobulin production to join our team as a consultant.
This is an exciting opportunity for a seasoned professional to leverage their expertise in large-scale plasma fractionation or recombinant protein production, with a strong focus on regulatory compliance and quality assurance.
- Develop and scale manufacturing processes for albumin and immunoglobulins.
- Provide technical guidance on technology selection, facility setup, and equipment procurement.
- Evaluate and ensure compliance with cGMP, FDA, EMA, DCGI, ICH, and WHO guidelines.
- Support the preparation of regulatory filings (IND, BLA, DMF, etc.) and strengthen legal/regulatory compliance.
- Implement quality control systems and mentor internal teams to build long-term organisational expertise.
To be successful in this role, you will need:
- An advanced degree (M.Sc./PhD) in biotechnology, biochemistry, or a related field.
- No less than 10 years' experience in biologics manufacturing, with specific expertise in albumin and immunoglobulins.
- A 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 the potential to scale into a director role.
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Microsoft Dynamics 365 Retail Consultant
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SAP Expert Lead
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