[Innovative Medicine]Principal Scientist, Drug Product Development and Delivery-Biologics (Asia-Pacific)
J&J Family of Companies
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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