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Product Development Specialist
2 weeks ago
We are seeking an experienced Product Development Specialist to join our team.
- Key Responsibilities:
- Independently design and develop analytical methods for protein products, adhering to ICH/USP/EP/IP guidelines.
- Collaborate with Cell Culture and Downstream teams in Biotech R&D.
- Establish product-related test/release specifications and analytical protocols.
- Coordinate with Quality Control for smooth implementation of new methods.
- Maintain equipment logs and documentation in the lab.
- Monitor product stability and prepare regulatory submission documents.
About the Role:
This role requires a highly skilled individual with expertise in HPLC-based analysis, method development, and transfer. The successful candidate will be responsible for designing and implementing analytical methods for protein products, ensuring compliance with regulatory guidelines.
Requirements:
- Thorough knowledge of HPLC-based analysis techniques.
- Strong understanding of ICH/USP/EP/IP guidelines.
- Ability to work independently and collaboratively within a team.
- Excellent communication and problem-solving skills.