Senior Biologics Production Specialist

2 days ago

Erode, Tamil Nadu, India beBeeManufacturing Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Albumin Manufacturing Expert

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

About the Role
  • Design and scale manufacturing processes for Albumin and Immunoglobulins.
  • Advise on technology selection, facility setup, and equipment procurement.
  • Evaluate compliance with cGMP, FDA, EMA, DCGI, ICH, and WHO guidelines.
  • Support regulatory filings (IND, BLA, DMF) and strengthen legal/regulatory compliance.
  • Implement quality assurance and quality control systems.
  • Mentor and train internal teams to build organisational expertise.

On successful engagement, you will transition into a Director role, leading operations, strategy, and global compliance for our Albumin & Immunoglobulin division.

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 (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.

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