
Albumin and Immunoglobulin Production Specialist
5 days ago
We are seeking a seasoned professional in Albumin and Immunoglobulin production to join our team as a Consultant, with opportunities for career advancement and leadership development.
This is an exciting chance to contribute to the growth and success of a cutting-edge biologics manufacturing program with lasting impact.
About the Role- Lead the design and scaling of manufacturing processes for Albumin and Immunoglobulins.
- Provide expert advice on technology selection, facility setup, and equipment procurement.
- Ensure compliance with regulatory frameworks such as cGMP, FDA, EMA, DCGI, ICH, and WHO.
- Support regulatory filings and strengthen legal/compliance expertise.
- Develop and implement quality assurance and quality control systems.
- Mentor and train internal teams to build long-term organizational capabilities.
Upon successful engagement, you will transition into a Director role, leading operations, strategy, and global compliance for our Albumin & Immunoglobulin division.
Key Requirements- Advanced degree 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 career growth.
- Experience engaging with regulatory authorities.
- Familiarity with intellectual property, licensing, and compliance in biologics.
- Knowledge of market access and global trade regulations.
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