Albumin and Immunoglobulin Production Specialist

6 days ago


Malappuram, Kerala, India beBeealbumin Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Albumin and Immunoglobulin Expert

We seek a seasoned expert in Albumin and Immunoglobulin production to drive our biologics manufacturing program forward.

About the Role:

  • Design, develop and scale manufacturing processes for Albumin and Immunoglobulins.
  • Provide strategic guidance on technology selection, facility setup and equipment procurement.
  • Maintain compliance with cGMP, FDA, EMA, DCGI, ICH and WHO regulations.
  • Support regulatory submissions (IND, BLA, DMF etc.) and ensure legal/regulatory compliance.
  • Establish quality assurance and control systems.
  • Mentor and train internal teams to build long-term organisational capabilities.

This role offers opportunities for growth and development, leading to a transition into a Director position overseeing operations, strategy and global compliance for our Albumin & Immunoglobulin division.

Requirements:

  • Advanced degree (M.Sc./PhD in Biotechnology, Biochemistry or related field).
  • Minimum 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 potential for career advancement.

Bonus 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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