Senior Biologics Manufacturing Specialist

1 day ago

Aurangabad, Maharashtra, India beBeeBiologics Full time ₹ 90,00,000 - ₹ 1,20,00,000
Albumin and Immunoglobulin Production Expert

This is a unique opportunity to shape and lead a cutting-edge biologics manufacturing program with long-term impact.

About the Role
  • We are seeking an experienced professional to design and scale manufacturing processes for Albumin and Immunoglobulins.
  • The ideal candidate will advise on technology selection, facility setup, and equipment procurement.
  • Evaluation of compliance with regulatory guidelines (cGMP, FDA, EMA, DCGI, ICH, WHO) is also required.
  • Supporting regulatory filings and strengthening legal/regulatory compliance are key responsibilities.
  • Implementation of quality assurance and control systems is essential.
  • Mentorship of internal teams to build organisational expertise is expected.
Requirements
  • An advanced degree in Biotechnology, Biochemistry, or a related field is mandatory.
  • At least 10 years' experience in biologics manufacturing with specific expertise in Albumin and Immunoglobulins is necessary.
  • A proven track record in large-scale plasma fractionation or recombinant protein production is required.
  • In-depth knowledge of regulatory frameworks (FDA, EMA, DCGI, ICH, WHO) is crucial.
  • Strong leadership qualities with potential to scale into a Director role are essential.
Bonus Skills
  • Experience engaging with regulatory authorities is desirable.
  • Familiarity with intellectual property, licensing, and compliance in biologics is beneficial.
  • Knowledge of market access and global trade regulations is advantageous.

As a senior expert in biologics manufacturing, you will have the opportunity to work on cutting-edge projects and contribute to the growth and success of our organisation.

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