
Senior Biologics Manufacturing Specialist
2 weeks ago
Biologics Manufacturing Expertise
About the Role:- We are seeking a highly experienced professional with advanced knowledge in biologics manufacturing, particularly in albumin and immunoglobulin production.
- The ideal candidate will have extensive experience in designing and scaling manufacturing processes, advising on technology selection, facility setup, and equipment procurement.
- A proven track record in regulatory compliance, including cGMP, FDA, EMA, DCGI, ICH, and WHO guidelines is essential.
Key Responsibilities:
- Design and scale up manufacturing processes for albumin and immunoglobulins.
- Advise on technology selection, facility setup, and equipment procurement to ensure optimal results.
- Maintain high levels of quality assurance and control through implementation of effective systems.
- Mentor and train internal teams to build long-term organisational expertise.
Requirements:
- Advanced degree (M.Sc./PhD) in Biotechnology, Biochemistry, or related field.
- Minimum 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.
- Strong leadership qualities and potential to scale into a Director role.
Bonus Skills:
- Experience engaging with regulatory authorities.
- Familiarity with intellectual property, licensing, and compliance in biologics.
- Knowledge of market access and global trade regulations.
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