Essential Functions of the Job:

Familiar with the establishment and optimization of large biomolecular HPLC/CE/Mass method;

Familiar with HPLC/CE method validation in release inspection and write method validation report after method validation;

Prepare qualified samples to ensure the smooth operation of pre-clinical；

Draft the original experiment record and filing documents for IND;

Take responsibility of the general operation of the protein analytical laboratory facilities;

Plan, execute and manage both routine and non-routine projects simultaneously with general criteria for results;

Other reasonably duties as requested by Company Senior Management from time to time.

Education Required:

Major in Pharmaceutical analysis or related field;

Above college related to bioprocessing or biopharmaceutical production.

Essential Experience:

College degree with a minimum of 2 years of large Biomolecule analysis experience; May have less experience in bachelor and above;

Master the theoretical knowledge of biochemistry;

Experience in drug registration verification is a plus.

Essential Functions of the Job:

Assist process development group to meet project timeline and departmental goals;

Familiar with the establishment and optimization of large biomolecular HPLC/CE/Mass method;

Familiar with HPLC/CE method validation in release inspection, and write method validation report after method validation;

Prepare qualified samples to ensure the smooth operation of pre-clinical；

Draft the original experiment record and filing documents for IND;

Take responsibility of the general operation of the protein Analytical laboratory facilities;

Assist superior to complete other work if needed.

Education Required:

Major in bioscience or related field;

Advanced post-graduate qualification (BS or MS) related to bioprocessing or biopharmaceutical production.

Essential Experience:

BS degree with a minimum of 0~3 years and MS degree with a minimum of 0~2 years of large Biomolecule analytical experience;

Familiar with the literature retrieval and relevant information inspection, and familiar with the IND filing;

Project management of CMC filing for US, EU, and China IND/CTA;

Familiar with office software and proficient in reading professional English;

Project management capability.