Senior Biomanufacturing Specialist

4 days ago


Anand, Gujarat, India beBeeBiologics Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Albumin and Immunoglobulin Manufacturing Expert

We are seeking an experienced professional in albumin and immunoglobulin production to help shape and lead our cutting-edge biologics manufacturing program.

About the Role:

  • Develop and implement efficient manufacturing processes for albumin and immunoglobulins.
  • Provide guidance on technology selection, facility setup, and equipment procurement.
  • Ensure compliance with regulatory guidelines including cGMP, FDA, EMA, DCGI, ICH, and WHO.
  • Support regulatory filings and strengthen legal/regulatory compliance.
  • Establish quality assurance and quality control systems.
  • Mentor and train internal teams to build long-term organisational expertise.

Requirements:

  • Advanced degree (M.Sc./Ph.D. 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 (FDA, EMA, DCGI, ICH, WHO).
  • Strong leadership qualities with 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.


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