Albumin Production Consultant

1 day ago


Kottayam, Kerala, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 25,00,000

Expert in Albumin and Immunoglobulin production sought to provide professional services as a consultant, with potential to transition into a leadership role.

About the Opportunity
  • Design and scale manufacturing processes for Albumin and Immunoglobulins.
  • Advise on technology selection, facility setup, and equipment procurement.
  • Evaluate compliance with regulatory guidelines such as cGMP, FDA, EMA, DCGI, ICH, and WHO.
  • Support regulatory submissions and strengthen legal/regulatory compliance.
  • Implement quality assurance and quality control systems.
  • Mentor and train internal teams.

As a director, lead operations, strategy, and global compliance for an Albumin & Immunoglobulin division.

Requirements
  • 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.
Preferred Skills
  • 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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