Essential Functions of the Job:

Manage a group of scientists and technicians to complete 1-2 Downstream projects in parallel approximately every six months;

Develop and improve methodologies and technologies relating to protein purification (focus on MAbs) including standard protocols based on product category;

Develop and improve methodologies and technologies relating to protein purification for intermediates and drug substance including standard protocols based on product category;

Authors’ protocols, reports, technology transfer protocols/reports and other technical documents (i.e. Process Description, specifications) as part of the product development and technology transfer process. Author documents align with CMC section of IND/CTD packages;

Support technical progress and regulatory filing of related products;

Supervise technology transfer to clinical manufacturing;

Take responsibility of the general operation and maintenance of the protein purification laboratory facilities;

Prepare and present capital expenditure requests for Downstream laboratory equipment;

Maintain effective, collaborative, and frequent interactions with client and other department to ensure harmonization in scientific and technical approaches;

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

Education Required:

Major in Pharmaceutics, Pharmaceutical Science or related field;

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

Essential Experience:

BS degree with a minimum of 4~6 years and MS degree with a minimum of 3~4 years of large Biomolecule purification experience;

Experience in managing staff of at least 2 technical specialists;

Expert knowledge in protein biochemistry related to protein purification and characterization of MAbs and recombinant proteins;

Advanced computer system skills for Microsoft Office suite (Word, Excel, Powerpoint, Project, Outlook);

Thorough practical knowledge of Chemistry Manufacturing and Controls for IND/CTA filing in China, USA and EU.