Senior Biologics Manufacturing Specialist

24 hours ago

Kolkata, West Bengal, India beBeeBiologics Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Biologics Manufacturing Expert

We are seeking a seasoned professional to spearhead our biologics manufacturing program, driving long-term impact and growth.

About the Role:

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

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

Requirements:
  • 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 for scaling 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.
Benefits:

This is a unique opportunity to shape and lead a cutting-edge biologics manufacturing program. On successful engagement, you will transition into the Director role, leading operations, strategy, and global compliance for our Albumin & Immunoglobulin division.

Key Responsibilities:

Lead the development and implementation of biologics manufacturing processes.

Collaborate with cross-functional teams to drive business growth and expansion.

Develop and maintain strong relationships with regulatory authorities and industry partners.

Pursue continued education and professional development opportunities.

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