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Manufacturing Expert for Biologics
3 weeks ago
We are seeking an accomplished professional to join our team as a Consultant, focusing on Albumin and Immunoglobulin production.
This is a unique opportunity to shape and lead a cutting-edge biologics manufacturing program with long-term impact.
About the Role- Develop and scale manufacturing processes for Albumin and Immunoglobulins.
- Advise on technology selection, facility setup, and equipment procurement.
- Ensure compliance with regulatory guidelines.
- Support regulatory filings and strengthen legal/regulatory compliance.
- Implement quality assurance and quality control systems.
- Mentor and train internal teams to build organisational expertise.
Upon successful engagement, you will transition into a Director role, leading operations, strategy, and global compliance for our Albumin & Immunoglobulin division.
Required Skills and Qualifications- Advanced degree (M.Sc./Ph.D. 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 frameworks.
- Strong leadership qualities with potential for scaling.
- Experience engaging with regulatory authorities.
- Familiarity with intellectual property, licensing, and compliance in biologics.
- Knowledge of market access and global trade regulations.
