Senior Biologics Manufacturing Specialist

4 days ago

Mangalore, Karnataka, India beBeeBiologics Full time ₹ 19,40,000 - ₹ 23,45,000

Albumin Consultant

About the Role:

  • Develop and optimize manufacturing processes for biologics, specifically Albumin.
  • Provide expertise in technology selection, facility setup, and equipment procurement.
  • Ensure adherence to regulatory frameworks (cGMP, FDA, EMA, DCGI, ICH, WHO).
  • Support regulatory submissions and strengthen compliance with relevant authorities.
  • Implement quality assurance and control systems.
  • Lead and train internal teams to build long-term organizational capabilities.

Required Skills and Qualifications:

  • Advanced degree (M.Sc./PhD) in Biotechnology, Biochemistry, or related field.
  • Minimum 10 years' experience in biologics manufacturing, with specific expertise in Albumin.
  • 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 skills with potential for career growth.

Benefits:

  • Opportunity to work on complex projects with high-impact results.
  • Collaborative team environment with expert colleagues.
  • Frequent professional development opportunities.

Bonus Skills:

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

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