Biologics Manufacturing Specialist

2 days ago

Ghaziabad, Uttar Pradesh, India beBeeBiologics Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

We are seeking a Biologics Manufacturing Expert to join our team in shaping the future of biologics production.

About the Role
  • Our ideal candidate will design and scale manufacturing processes for Albumin and Immunoglobulins, ensuring compliance with global regulations.
  • The successful candidate will advise on technology selection, facility setup, and equipment procurement, driving efficiency and innovation in biologics manufacturing.
  • This role requires expertise in regulatory frameworks, including cGMP, FDA, EMA, DCGI, ICH, and WHO guidelines.
  • The selected individual will support regulatory filings and strengthen legal/regulatory compliance, guaranteeing high-quality products.
  • Additionally, they will implement quality assurance and quality control systems, mentoring and training internal teams to build long-term organisational expertise.
Requirements
  • An advanced degree (M.Sc./PhD) in Biotechnology, Biochemistry, or a related field is essential for this role.
  • At least 10 years' experience in biologics manufacturing, with specific expertise in Albumin and Immunoglobulins, is required.
  • The ideal candidate should have a proven track record in large-scale plasma fractionation or recombinant protein production.
  • In-depth knowledge of regulatory frameworks is crucial for success in this position.
  • Strong leadership qualities, with the potential to scale into a Director role, are highly desirable.
Bonus Skills
  • Experience engaging with regulatory authorities will be beneficial.
  • Familiarity with intellectual property, licensing, and compliance in biologics is advantageous.
  • Knowledge of market access and global trade regulations is a plus.

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