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2 days ago
Key responsibilities include designing, scaling, and implementing large-scale production systems for Albumins and Immunoglobulins. The ideal candidate will also advise on technology selection, facility setup, and equipment procurement while ensuring compliance with regulatory frameworks such as cGMP, FDA, EMA, DCGI, ICH, and WHO.
To be successful in this role, you should have an advanced degree in Biotechnology, Biochemistry, or a related field, coupled with 10+ years' experience in biologics manufacturing, specifically in Albumin and Immunoglobulins. A proven track record in large-scale plasma fractionation or recombinant protein production, as well as in-depth knowledge of regulatory frameworks, are also essential.
Bonus Skills
- Experience engaging with regulatory authorities is advantageous.
- Familiarity with intellectual property, licensing, and compliance in biologics is a plus.
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