Shanghai, CHN
10 hours ago
[Innovative Medicine]Principal Scientist, Drug Product Development and Delivery-Biologics (Asia-Pacific)
The successful candidate for Drug Product Development & Delivery(DPD&D)- Biologics, Asia-pacific, will work closely with global Th erapeutics Development and Supply (TDS) and external partners on biologics drug product development in Asia Pacific region. Responsibilities include but are not limited to: + Lead formulation/process development study to support Biologics DP development activities at external sites; + Write and/or review technical documents including study reports, batch records, memos; + Interface with different functional groups and communicate effectively with internal and external partners; + Act as subject matter expert on f ormulation/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; + Partners with cross functional groups to ensure processes are consistent with J&J platforms and are in compliance with the submitted CMC dossiers and general cGMP regulations. **Qualifications** + PhD or other advanced degree in Pharmaceutical Sciences, Chemical Engineering or a related field with at least 3 years of experience. Candidates with MS degree in a related field and at least 6 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 s kills in both writing and speaking in English is highly 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 a bility to collaborate with cross functional teams. + Up to 30% domestic and international travel
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