Senior Biologics Manufacturing Specialist

3 days ago

Kozhikode, Kerala, India beBeeBiotechnology Full time ₹ 2,50,00,000 - ₹ 3,50,00,000

Albumin and Immunoglobulin Expert

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We are seeking an experienced professional to join our team as a Consultant, focusing on Albumin and Immunoglobulin production. This is a unique opportunity to shape and lead a cutting-edge biologics manufacturing program with long-term impact.

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

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

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What We're Looking For

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  • 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.
  • Strong leadership qualities with potential for growth.

Bonus Skills

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  • Experience engaging with regulatory authorities.
  • Familiarity with intellectual property, licensing, and compliance in biologics.
  • Knowledge of market access and global trade regulations.

Engagement Terms

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  • Phase 1: Consultant (part-time/flexible, project-based).
  • Phase 2: Full-time Director of Albumin & Immunoglobulin Production.

How to Apply

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If you have the expertise and vision to lead Albumin and Immunoglobulin manufacturing into the future, please submit your CV and a short cover note highlighting relevant projects and achievements.

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