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Albumin and Immunoglobulin Biologics Manufacturing Specialist
2 weeks ago
This is a unique opportunity to shape and lead a cutting-edge biologics manufacturing program with long-term impact.
About the Position- We are seeking an experienced professional to design and scale manufacturing processes for Albumin and Immunoglobulins.
- You will be responsible for selecting technology, setting up facilities, and procuring equipment.
- You must ensure compliance with regulatory guidelines (cGMP, FDA, EMA, DCGI, ICH, WHO).
- Supporting regulatory filings and strengthening legal/regulatory compliance is also part of this role.
- Implementing quality assurance and control systems is essential for success in this position.
- An advanced degree in Biotechnology or Biochemistry is required.
- You should have 10+ years' experience in biologics manufacturing with Albumin and Immunoglobulins expertise.
- A proven track record in large-scale plasma fractionation or recombinant protein production is necessary.
- In-depth knowledge of regulatory frameworks (FDA, EMA, DCGI, ICH, WHO) is crucial.
- Strong leadership qualities with potential for Director role are desired.
- Engagement with regulatory authorities would be beneficial.
- Familiarity with intellectual property, licensing, and compliance in biologics would be advantageous.
- Knowledge of market access and global trade regulations could enhance your skills in this field.
