Biologics Manufacturing Specialist

2 days ago

Vijayawada, Andhra Pradesh, India beBeeManufacturing Full time ₹ 15,00,000 - ₹ 25,00,000

About the Role

  • We seek a seasoned expert to lead the development and scaling of manufacturing processes for Albumin and Immunoglobulins.
  • The ideal candidate will advise on technology selection, facility setup, and equipment procurement to ensure operational efficiency.
  • Regulatory compliance is paramount; our team member must be well-versed in cGMP, FDA, EMA, DCGI, ICH, and WHO guidelines.
  • Supporting regulatory filings (IND, BLA, DMF) and strengthening legal/regulatory compliance are also key responsibilities.
  • A quality assurance and control system will be implemented under their guidance.
  • Mentorship and training internal teams will be essential for building long-term organisational expertise.

What We're Looking For

  • A minimum advanced degree (M.Sc./PhD) in Biotechnology, Biochemistry, or a related field is required.
  • The successful candidate will have at least 10 years' experience in biologics manufacturing, with specific expertise in Albumin and Immunoglobulins.
  • A proven track record in large-scale plasma fractionation or recombinant protein production is expected.
  • In-depth knowledge of regulatory frameworks (FDA, EMA, DCGI, ICH, WHO) is necessary.
  • Strong leadership qualities with potential to scale into a Director role are essential.

Bonus Skills

  • Experience engaging with regulatory authorities will be advantageous.
  • Familiarity with intellectual property, licensing, and compliance in biologics will be an added value.
  • Knowledge of market access and global trade regulations may be beneficial.

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