- Lead efforts for analytical development, stability studies within ASC department; function as project leader role in analytical & stability projects for biologic drug products
- Plan and execute batch release, stability study for biologics of drug substances/drug products; perform stability and release analyses, but not limited to samples for drug substances /drug products used for clinical trials
- Author, review and/or approve the analytical methods, method validation reports, stability study reports, Certificate of Analysis (CoA), summaries/reports, etc.
- Be responsible for project management from project plan/execution/following up, and completion. Also responsible to maintain high level of GMP in analytical lab. Assist the interaction with the clients by issuing project reports, entertaining on-site visitation and participate in tele-, web- or video-conferencing, etc.
- Work closely with supervisor to meet project timelines, departmental goal, and customer requests. Be responsible for improving the operation efficiency and productivity while ensuring the current quality systems in full compliance to all applicable regulatory standards
- Coach junior analysts and provide the training in technology and compliance to them as needed. Assist supervisor to coordinate and oversee the work activities of scientific staff within the assigned group
- Ph.D. or Master degree in analytical chemistry, bio-analytical chemistry, biological sciences, biology and/or other related science discipline with experience in analysis of biologic DS and DP
- Must have 2-5 years hands-on experiences in SDS-Page, ELISA, SEC, CE, UPLC and bioanalytical technologies and able to independently work on the biologic drug product analysis
- Familiar with requirements of FDA, CFDA, cGMP/GLP regulations, and ICH guidelines in analytical & stability requirement
- Supervisory experience in a pharmaceutical R&D environment in both project and people management is desirable
- Good communication skills in both written and verbal and interpersonal interaction skill are essential job requirements
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