
Albumin and Immunoglobulin Manufacturing Specialist
3 days ago
We are seeking a seasoned professional to guide our team in designing and scaling production processes for Albumin and Immunoglobulins.
This role offers the opportunity to transition into a full-time Director of Albumin & Immunoglobulin Production, leading operations, strategy, and global compliance for our division.
Responsibilities:- Design and scale manufacturing processes for Albumin and Immunoglobulins.
- Advise on technology selection, facility setup, and equipment procurement.
- Ensure compliance with regulatory guidelines (cGMP, FDA, EMA, DCGI, ICH, WHO).
- Support regulatory filings (IND, BLA, DMF, etc.) and strengthen legal/regulatory compliance.
- Implement quality assurance and quality control systems.
- Mentor and train internal teams to build long-term organisational expertise.
- 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.
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