Albumin Manufacturing Expert

3 days ago

Hubli, Karnataka, India beBeeBiologics Full time ₹ 10,00,000 - ₹ 15,00,000

Albumin Specialist

We are seeking a highly experienced expert in albumin and immunoglobulin manufacturing to join our team.

About the Role:

  • Develop and optimize large-scale production processes for albumin and immunoglobulins, ensuring efficient use of resources and equipment.
  • Provide strategic advice on technology selection, facility setup, and procurement, enabling informed business decisions.
  • Maintain strict compliance with regulatory guidelines, including cGMP, FDA, EMA, DCGI, ICH, and WHO standards.
  • Collaborate on regulatory filings and enhance legal/regulatory compliance within the organization.
  • Implement robust quality assurance and quality control systems to ensure high-quality products.
  • Mentor and train internal teams to foster long-term organizational expertise and capability.

Successful engagement will lead to a director role, overseeing operations, strategy, and global compliance for the albumin and immunoglobulin division.

Requirements:

  • Advanced degree (M.Sc./PhD) in Biotechnology, Biochemistry, or a related field.
  • 10+ years of 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 and ability to adapt to changing regulations.
  • Strong leadership qualities with potential to scale into a director role.

Bonus Skills:

  • Experience engaging with regulatory authorities and influencing policy decisions.
  • Familiarity with intellectual property, licensing, and compliance in biologics.
  • Knowledge of market access and global trade regulations, enabling effective navigation of complex markets.

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