Johnson & Johnson Careers
Requisition ID: 1805689319W
The successful candidate for China Biotherapeutics Drug Product Development (DPD) will work closely with global Biotherapeutics Development (BTD) and external partners on biologics drug product development in Asia Pacific region. Responsibilities include but are not limited to:
• Conduct formulation development study to support DP development activities at both internal and external sites
• Write and/or review technical documents including study reports, batch records, memos and execute experiments;
• Interface with different functional groups and communicate effectively with internal and external partners;
• Acts as subject matter expert for scientific aspects of formulation development, excipients and container closure.
• Comply with company policy during daily operation, ensure data integrity to support authoring regulatory documents;
• Draft regulatory filing documents in China and perform technical review.
• Partners with cross functional groups to ensure processes are consistent to accepted Janssen platforms and are in compliance with the submitted CMC dossiers and general cGMP regulations.
• 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;
• Previous experience in a GMP working environment is highly preferred;
• Good communication skills 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. Ability to collaborate with cross functional teams is a must.
• Up to 30% domestic and international travel
J&J (China) Investments Ltd (7046)