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Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Biotherapeutics R&D
Job Category:Scientific/Technology
All Job Posting Locations:Shanghai, China
Job Description:The successful candidate for Drug Product Development & Delivery (DPD&D)- Biologics, Asia-pacific, will work closely with global Therapeutics Development and Supply (TDS) team and external partners on biologics drug product development in Asia Pacific region. Responsibilities include but are not limited to:
- Lead formulation/process development studies to support Biologics DP development activities at external sites;
- Write and/or review technical documents including study protocol and reports, batch reports, technical memos;
- Interface with different functional groups and communicate effectively with internal and external partners, ensuring processes are consistent with J&J platforms and are in compliance with the submitted CMC dossiers and general cGMP regulations.
- Act as subject matter expert on formulation/process development, excipients and container closure;
- Comply with company policy during daily operation, ensure data integrity to support authoring regulatory documents;
- Draft regulatory filing documents and perform technical review;
Qualifications• PhD or other advanced degree in Pharmaceutical Sciences, Chemical Engineering or a related field with at least 4 years of experience. Candidates with MS degree in a related field and at least 8 years of working experience will also be considered;
• Solid knowledge in biologics drug product development is a must;
• Antibody drug conjugate (ADC) development and manufacturing experience are highly preferred;
• Previous experience in a GMP working environment is highly preferred;
• Good communication skills in both writing and speaking in English is preferred;
• Experience with multi-national pharmaceutical companies is preferred;
• Experience of the biologics drug dosing design and administration in various clinical development stages is a plus;
• Proven track record of creativity and problem solving and ability to collaborate with cross functional teams.
• Up to 30% domestic and international travel
Primary Location: Shanghai- China
Report to: DPD&D-Biologics, Asia-pacific lead
Required Skills: Preferred Skills:Analytical Reasoning, Biochemistry, Biotechnology, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Coaching, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Organizing, Pharmacovigilance, Presentation Design, Process Improvements, Productivity Planning, Scientific Research
