
Director of Biologics Manufacturing
1 day ago
Key role in Albumin and Immunoglobulin production is available as we expand our biologics manufacturing program.
About the Role- Expertise is sought in designing and scaling up manufacturing processes for Albumin and Immunoglobulins.
- Advice will be provided on technology selection, facility setup, and equipment procurement to support compliance with regulatory guidelines.
- Regulatory filings and legal/compliance strengthening are also key aspects of this position.
- Quality assurance and control systems must be implemented to ensure process excellence.
- Mentoring internal teams to build organisational expertise is a critical requirement.
The successful candidate will lead operations, strategy, and global compliance for our Albumin & Immunoglobulin division as Director.
Requirements- Advanced degree (M.Sc./PhD in Biotechnology, Biochemistry, or related field) is necessary for this position.
- 10+ years' experience in biologics manufacturing, with specific expertise in Albumin and Immunoglobulins is required.
- A proven track record in large-scale plasma fractionation or recombinant protein production is essential.
- In-depth knowledge of regulatory frameworks is a must.
- Strong leadership qualities are required to succeed in this role.
- Experience engaging with regulatory authorities would be beneficial.
- Familiarity with intellectual property, licensing, and compliance in biologics would be an advantage.
- Knowledge of market access and global trade regulations would be useful.
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