
Expert in Albumin and Immunoglobulin Manufacturing
2 days ago
We are seeking an expert in albumin and immunoglobulin manufacturing to drive our biologics program forward.
This role presents a unique chance to shape the future of albumin and immunoglobulin production, contributing to long-term impact on the industry.
About the Role- Develop and scale manufacturing processes for albumin and immunoglobulins, providing strategic guidance and operational expertise.
- Advise on technology selection, facility setup, and equipment procurement, ensuring seamless integration with existing infrastructure.
- Maintain regulatory compliance through active engagement with relevant authorities and thorough risk assessments.
- Support the preparation and submission of regulatory filings, reinforcing legal and regulatory compliance.
- Implement quality assurance and control systems, fostering a culture of excellence and continuous improvement.
- Mentor and train internal teams to build organisational capabilities and promote knowledge sharing.
Upon successful engagement, you will transition into a Director role, overseeing operations, strategy, and global compliance for our albumin and immunoglobulin division.
Key Requirements- Advanced degree (M.Sc./PhD in Biotechnology, Biochemistry, or related field).
- At least 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, demonstrating technical leadership and innovation.
- In-depth knowledge of regulatory frameworks and compliance regulations.
- Strong leadership qualities, with potential to scale into a Director role, driving team performance and achieving business objectives.
- Experience engaging with regulatory authorities and navigating complex regulatory environments.
- Familiarity with intellectual property, licensing, and compliance in biologics, including market access and global trade regulations.
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