Johnson & Johnson Careers
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Senior Scientist, Formulation
Requisition ID: 1700204438W
The successful candidate for China Large Molecule (LM) Drug Product Development (DPD) will work closely with global Pharmaceutical Development and Manufacturing Sciences (PDMS) and external partners on biologics drug product development in Asia Pacific region. Responsibilities include but are not limited to:
- Provide technical support of fill finish process of large molecule drug product at both internal and external sites including tech transfer, review of manufacturing documents, and continuous improvement of the process;
- Draft process development documents for engineering run, PPQ and clinical manufacturing;
- Interface with different functional groups and communicate effectively with internal and external partners;
- Participate in deviation investigation during DP manufacturing activities;
- Comply with company policy during daily operation, ensure data integrity to support drafting regulatory documents;
- Perform technical review of regulatory filing documents in China.
· 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 and manufacturing process is a must;
· 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 highly preferred
· Experience of the biologics drug dosing design and administration in various clinical development stages is a plus;
· Up to 30% domestic and international travel
J&J (China) Investments Ltd (7046)