
Albumin and Immunoglobulin Production Specialist
6 days ago
Biologics Manufacturing Expert Wanted
About the Role:
- Develop and scale manufacturing processes for albumin and immunoglobulins.
- Provide guidance on technology selection, facility setup, and equipment procurement.
- Ensure compliance with regulatory frameworks, including cGMP, FDA, EMA, DCGI, ICH, and WHO.
- Support regulatory submissions and strengthen legal/compliance capabilities.
- Implement quality assurance and control systems.
- Mentor and train internal teams to enhance organisational expertise.
Requirements:
- Advanced degree in Biotechnology, Biochemistry, or related field.
- 10+ years' experience in biologics manufacturing, with specific expertise in albumin and immunoglobulins.
- Proven track record in large-scale plasma fractionation or recombinant protein production.
- In-depth knowledge of regulatory environments.
- Strong leadership qualities with potential to scale into a director role.
Desirable Skills:
- Experience interacting with regulatory bodies.
- Familiarity with intellectual property, licensing, and compliance in biologics.
- Knowledge of market access and global trade regulations.
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