Biologics Manufacturing Specialist

7 days ago

Bellary, Karnataka, India beBeeBiologics Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Biologics Manufacturing Specialist

We are seeking a Biologics Manufacturing Specialist to join our team in shaping the future of Albumin and Immunoglobulin production.

This is an exceptional opportunity for you to lead cutting-edge biologics manufacturing programs, design and scale manufacturing processes for Albumin and Immunoglobulins, advise on technology selection, facility setup, and equipment procurement. You will ensure compliance with cGMP, FDA, EMA, DCGI, ICH, and WHO guidelines.

You will also support regulatory filings (IND, BLA, DMF, etc.) and strengthen legal/regulatory compliance. Additionally, you will implement quality assurance and quality control systems, mentor and train internal teams to build organisational expertise.

Key Responsibilities
  • Design and scale manufacturing processes for Albumin and Immunoglobulins.
  • Advise on technology selection, facility setup, and equipment procurement.
  • Ensure compliance with cGMP, FDA, EMA, DCGI, ICH, and WHO guidelines.
  • Support regulatory filings (IND, BLA, DMF, etc.).
  • Implement quality assurance and quality control systems.
  • Mentor and train internal teams.
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.
  • Strong leadership qualities.
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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