Responsible for the development, optimization, qualification and transfer of analytical methods. Responsible for the review of related documents. Supporting process development, comparability study and tech transfer. Responsible for the establishment and optimization of biochemical analytical platform.
Responsible for the troubleshooting and improvement of physicochemical analytical methods, and new technology introduction (SEC，IEC，CE_NR&R, et, al.) to meet the analytical needs of process development and manufacturing;
Responsible for the review of internal or external physicochemical related study protocol and reports. Provide technical expertise and oversight on analytical method transfer, trouble shooting, in-process and release testing procedures.
Responsible for the comparability studies and tech transfer projects (physicochemical analysis). Cooperate well with USP &DSP &QC&MST&MFG to promote project progress.
Support regulatory submissions by authoring relevant sections of IND, BLA/NDA and replying to health authority inquiry.
Responsible for providing guidance and training about experiment design, study design and troubleshooting to junior colleagues.
Responsible for the IQ, OQ and PQ of related analytical instruments. Responsible for the daily work of the laboratory.
To comply with the requirements of the EHS policies and regulations.
Any other assignment as is determined by supervisor.
Qualifications
Be familiar with analytical methods such as SEC，IEC，CE_NR&R, et, al.. Be familiar with DLS and DSC. Be familiar with analytical method development, optimization, qualification and transfer. Be familiar with process development and comparability study. Experience in analytical method lifecycle management.
Able to design experiments independently and make judgment and improvement according to the results, strong scientific thinking and logical judgment ability. Ability to solve problems based on experience during the project
Have systematic professional knowledge and strong experimental skills, able to lead team members to complete main projects.
Demonstrated experience in designing, developing, optimizing and troubleshooting assays is required. Knowledge of CMC regulatory requirements (FDA, EMA, NMPA, ICH).
At least 4 years of practical experience in Bio-pharmaceutical industry for Ph.D. degree.
At least 10 years of practical experience in Bio-pharmaceutical industry for MS degree.
