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6 days ago
We are seeking a seasoned professional with expertise in Albumin and Immunoglobulin production to fill the role of an experienced Consultant.
About the Job- Develop and scale manufacturing processes for Albumin and Immunoglobulins, ensuring compliance with regulatory guidelines.
- Select technology, set up facilities, and procure equipment, optimizing operational efficiency.
- Maintain compliance with cGMP, FDA, EMA, DCGI, ICH, and WHO regulations.
- Support regulatory filings and strengthen legal/regulatory compliance, minimizing risk.
- Implement quality assurance and quality control systems, promoting product excellence.
- Mentor and train internal teams to build expertise, driving organizational growth.
As a leader in operations, strategy, and global compliance, you will drive success for our Albumin & Immunoglobulin division.
Requirements- 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.
- Strong leadership qualities with potential for growth.
The ideal candidate will possess a unique blend of technical expertise, business acumen, and leadership skills, enabling them to drive innovation and success within our organization.
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