Biologics Manufacturing Expert

4 days ago

Ajmer, Rajasthan, India beBeeManufacturing Full time ₹ 30,00,000 - ₹ 35,00,000
Biologics Manufacturing Expert - Albumin and Immunoglobulins

Job Description:

We are seeking a highly experienced Biologics Manufacturing Expert to join our team in designing and scaling manufacturing processes for Albumin and Immunoglobulins. As a key member of our team, you will be responsible for advising on technology selection, facility setup, and equipment procurement while ensuring compliance with cGMP, FDA, EMA, DCGI, ICH, and WHO guidelines.

Key Responsibilities:

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

Requirements:

To succeed in this role, you will need:

  • An 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
  • A proven track record in large-scale plasma fractionation or recombinant protein production
  • In-depth knowledge of regulatory frameworks
  • Strong leadership qualities with the potential to scale into a Director role

What We Offer:

This is an exciting opportunity to join our team and contribute to the development of innovative biologics manufacturing processes. As a Biologics Manufacturing Expert, you will have the chance to work with a talented team of professionals, develop your skills, and take on new challenges.

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