Key Responsibilities:
1. Ensure accuracy and efficiency in testing procedures to support the nomination of potential drug candidates (including ADC, mAb, BsAb, etc.).
2. Collaborate with cross-functional teams to ensure data integrity and alignment with project goals. Support process development to generate analytical data to enable cell line development, upstream, downstream, formulation and bio-conjugation process development.
3. Documentation of results and complete records in accordance with Company’s policies and relevant guidelines to ensure regulatory compliance.
4. Show flexibility and adaptability to comply with evolving lab protocols and management directives.
5. Develop analytical platform to meet requirements during different phases of CMC development.
6. Support IND/BLA dossier preparation, mange business partners such as CDMOs.
Key Requirements:
1. Bachelor’s degree or above in analytics, chemistry, biology or relevant disciplines.
2. 5+ years of analytical sciences experience in pharmaceutical industry.
3. Skilled in analytical technologies, such as HPLC, CE, UV etc.
4. Excellent communication and execution skills.