
Albumin and Immunoglobulin Production Expert
2 days ago
We are seeking a highly skilled expert in albumin and immunoglobulin production to join our organization.
This is an exceptional opportunity to lead and shape a cutting-edge biologics manufacturing program with long-term impact.
About the Role- Develop and scale up manufacturing processes for albumin and immunoglobulins.
- Provide technical advice on technology selection, facility setup, and equipment procurement.
- Evaluate and ensure compliance with cGMP, FDA, EMA, DCGI, ICH, and WHO guidelines.
- Support regulatory filings (IND, BLA, DMF, etc.) and enhance legal/regulatory compliance.
- Implement quality assurance and control systems.
- Mentor and train internal teams to build long-term organizational expertise.
As a specialist, you will have the opportunity to transition into a full-time director of albumin and immunoglobulin production as we expand.
Requirements- Bachelor's/Master's degree in Biotechnology, Biochemistry, or related field.
- At least 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.
This position offers the opportunity to work on high-profile projects and contribute to the development of novel therapeutic products.
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