Job Title: Analysis Manager/Director

Responsibilities:

Undertake the comprehensive management and system construction of R&D analytical labs (physical and chemical analysis, biological activity, and quality characterization), develop, revise, review and maintain laboratory management procedures, and ensure efficient operation of the R&D analytical labs according to GLP, ICH, CFDA and other related requirements;

Organize and supervise the model selection, procurement, testing, validation and maintenance of lab instruments and equipment, and establish SOPs for instrument utilization and maintenance;

Organize and conduct the development and validation of physical and chemical detection methods, including LC-MS, U/HPLC and CE, and develop biological activity assays based on ELISA and cell viability;

Organize and conduct testing and stability and quality attribute studies of products (including intermediates, stock solution, finished products and reference products);

Organize and conduct studies on product-related substances and process-related impurities, and develop and implement related test and characterization methods;

Organize and conduct product quality tracking and testing and preliminary stability study during the process R&D phase;

Review and analyze original experimental records and reports, and establish procedures for the management and storage of original records as well as the storage and backup of electronic data to ensure data authenticity and traceability;

Undertake the analysis, compilation and summary of lab test data, and work with the R&D department to develop quality standards for the products (including intermediates, stock solution, finished products and reference products);

Undertake the transfer and receiving of test methods, and review transferred protocols, records and reports;

Follow and track the progress in analytical techniques and the updates in relevant laws and regulations, and provide guidance for the maintenance and update of related lab test methods;

Prepare and review the quality section of application documents, and communicate and coordinate with the registration departments.

Qualifications:

Experience in IND application for macromolecular drugs, management of analysis teams, and QC or R&D analysis;

Bachelor’s degree or above in pharmaceutical analysis, medicine, biotechnology, bioengineering or other related fields;

Over 5 years (Master's degree) or 2 years (PhD) of working experience in pharmaceutical analysis (years of experience can be adjusted for suitable candidates);

Familiarity with CP/USP/ EP, GMP and related laws and regulations is preferred;

Rigorous and responsible; adequate analysis and problem-solving skills and excellent communication skills.

If you are interested in this position, please send your resume to us!

Beijing:renshanghe@sumgenbio.com   +86-10-56315401-808 Ms. Ren

Hangzhou/Shanghai:hr@sumgenbio.com  +86-571-86837379 Ms. Zhao

Copyright Rm. 301, F3, Building C, Block 2, No. 688, Bin'an Road, Changhe Zhejiang ICP Filing No. 18039044