
Albumin and Immunoglobulin Manufacturing Lead
6 days ago
We are seeking an experienced professional to lead the development of cutting-edge biologics manufacturing processes for Albumin and Immunoglobulins.
About the Role- Design, scale up, and optimize manufacturing processes for Albumin and Immunoglobulins.
- Provide technical expertise in technology selection, facility setup, and equipment procurement.
- Ensure compliance with cGMP, FDA, EMA, DCGI, ICH, and WHO guidelines through effective quality assurance and quality control systems.
- Mentor and train internal teams to build long-term organizational capabilities.
- Advanced degree (M.Sc./Ph.D.) in Biotechnology, Biochemistry, or a related field.
- Minimum 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 and potential for growth into a Director role.
- Familiarity with intellectual property, licensing, and compliance in biologics.
- Knowledge of market access and global trade regulations.
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