
Albumin and Immunoglobulin Manufacturing Specialist
11 hours ago
We are seeking a seasoned expert in Albumin and Immunoglobulin production to join our team as a consultant, with the opportunity to transition into a full-time Director of Albumin & Immunoglobulin Production as we expand.
This is a unique chance to help shape and lead a cutting-edge biologics manufacturing program with long-term impact.
About the Role- Guide us in designing and scaling manufacturing processes for Albumin and Immunoglobulins.
- Advise on technology selection, facility setup, and equipment procurement.
- Ensure compliance with cGMP, FDA, EMA, DCGI, ICH, and WHO guidelines.
- 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.
On successful engagement, you will transition into the Director role, leading operations, strategy, and global compliance for our Albumin & Immunoglobulin division.
What We're Looking For- 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.
- Phase 1: Consultant (part-time/flexible, project-based).
- Phase 2: Full-time Director of Albumin & Immunoglobulin Production.
If you have the expertise and vision to lead Albumin & Immunoglobulin manufacturing into the future, please send your CV and a short cover note highlighting relevant projects and achievements.
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