Pharmaceutical Downstream Process Development Specialist
hace 1 mes
Role Summary
As a DSP Process Development Scientist at Panda International, you will play a key role in developing and optimizing processes for Active Pharmaceutical Ingredient (API) production. This position requires a strong background in biotechnology, biochemical engineering, or a related field, with a minimum of 5 years of experience in downstream process development for API production, focusing on GMP standards.
Key Responsibilities
- Design, develop, and optimize downstream processes for API production, ensuring high yield, purity, and scalability.
- Design new DSP processes, optimization, and execute laboratory development work.
- Draft protocols, batch records, SOPs, and other relevant documents.
- Project planning and management to achieve deadlines.
- Ensure compliance with GMP and safety regulations in all activities.
- Monitor internal and external developments in the field for applicability.
- Develop and run AKTA FPLC purification protocols using different chromatography techniques.
- Develop and run tangential flow filtration systems (TFF).
- Manage project timelines, ensuring alignment with development milestones and strategic goals.
Requirements
- PhD or Master's degree in biological sciences, biotechnology, biochemical engineering, or related field.
- Minimum of 5 years of experience in downstream process development for API production, with a strong focus on GMP standards.
- In-depth knowledge of ICH guidelines and regulatory requirements for pharmaceutical development.
- Expertise in purification techniques such as chromatography (affinity, ion exchange), filtration, and protein recovery.
- Experience with process scale-up, including technology transfer and production-scale optimization.
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