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7 days ago
We seek a highly skilled consultant with expertise in Albumin and Immunoglobulin production to lead our team in designing and scaling manufacturing processes. This individual will also advise on technology selection, facility setup, and equipment procurement, ensuring compliance with cGMP, FDA, EMA, DCGI, ICH, and WHO guidelines.
- Guide the design and scaling of manufacturing processes for Albumin and Immunoglobulins.
- Advise on technology selection, facility setup, and equipment procurement.
- Ensure compliance with relevant regulatory frameworks.
- 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 the potential to scale into a Director role.
- Experience engaging with regulatory authorities.
- Familiarity with intellectual property, licensing, and compliance in biologics.
- Knowledge of market access and global trade regulations.
This is an exciting opportunity for a talented professional to join our team and contribute their expertise to drive success in Albumin and Immunoglobulin production.
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