Biologics Manufacturing Specialist

2 days ago

Meerut, Uttar Pradesh, India beBeeBiochemist Full time ₹ 20,00,000 - ₹ 30,00,000
Albumin and Immunoglobulin Production Expertise Required

We are seeking a seasoned professional to provide strategic guidance on the design, scaling, and implementation of Albumin and Immunoglobulin production processes.

This is an exceptional opportunity for a biologics manufacturing expert with specific knowledge of Albumin and Immunoglobulins to make a meaningful impact in our organisation.

About the Role
  • Lead the development of advanced manufacturing processes for Albumin and Immunoglobulins.
  • Advise on technology selection, facility setup, and equipment procurement strategies.
  • Ensure compliance with cGMP, FDA, EMA, DCGI, ICH, and WHO guidelines.
  • Support regulatory filings (IND, BLA, DMF, etc.) and strengthen legal/regulatory compliance.
  • Implement quality assurance and quality control systems.
  • Mentor and train internal teams to build long-term organisational expertise.
Key Qualifications
  • 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 (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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