Albumin and Immunoglobulin Manufacturing Specialist

11 hours ago


Kota, Rajasthan, India beBeeBiologics Full time ₹ 1,00,00,000 - ₹ 1,20,00,000

We are looking for a skilled professional to join our team as a Consultant, with the opportunity to transition into a full-time Director role.

This is a unique chance to help shape and lead a cutting-edge biologics manufacturing program with long-term impact.

About the Role
  • As a consultant, you will guide us in designing and scaling manufacturing processes for Albumin and Immunoglobulins.
  • You will advise on technology selection, facility setup, and equipment procurement.
  • You must ensure compliance with regulatory frameworks such as cGMP, FDA, EMA, DCGI, ICH, and WHO guidelines.
  • You will support regulatory filings (IND, BLA, DMF, etc.) and strengthen legal/regulatory compliance.
  • You will implement quality assurance and quality control systems.
  • You will mentor and train internal teams to build long-term organisational expertise.
Requirements
  • An advanced degree in Biotechnology, Biochemistry, or a related field.
  • At least 10 years of experience in biologics manufacturing, with specific expertise in Albumin and Immunoglobulins.
  • A 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.
Bonus Skills
  • Experience engaging with regulatory authorities.
  • Familiarity with intellectual property, licensing, and compliance in biologics.
  • Knowledge of market access and global trade regulations.
Engagement Terms
  • Phase 1: Consultant (part-time/flexible, project-based).
  • Phase 2: Full-time Director of Albumin & Immunoglobulin Production.
How to Apply

If you have the expertise and vision to lead biologics manufacturing into the future, please send your CV and a short cover note highlighting relevant projects and achievements.



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