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Position: Principal/Senior Scientist (Formulation)
Department: APAC Self Care R& D
Line Manager Position: Research Manager
Location: Shanghai Min Hang (STaR)
1. Act as project lead for Asia-Pacific innovation projects. Work with cross functional team to design product per specific business strategies.
2. Be responsible for implementation of NPD projects: take charge of pre-formulation study, formula screen, process design and optimization; complete IND batch production; coordinate preparation of NDA batch and clinical samples.
3. Be responsible for the technique transfer of NPD projects: take charge of technique and production documents written, complete technique transfer, scale up and process validation.
4. Actively interact with QA, Supply Chain, Medical & Regulatory Affairs teams to ensure effective technology transfer.
5. Be responsible for the drafting of pharmaceutical section within application dossier for new product, assist IND/NDA submission.
6. Manage projects and ensure development milestones are reached on time within target.
7. Manage external institutions, CROs, and technology development companies to ensure smooth project execution.
8. Support the BD team with potential technical due diligence work. Provide technical assessments on potential M&A deals.
1. A minimum of Master Degree in Medicine Pharmaceutics, or Chemistry related fields.
2. At least 3 years (Doctor) or 5 years (Master) of experience with OTC or Generic drug formulation Development and technical transfer.
3. Knowledge and experience in oral liquid, solid and semi-solid formula and process design and development
4. Knowledge and experience in oral liquid and solid products process validation (PV)
5. Knowledge of QbD (Quality by Design) required
6. Knowledge of Regulations，GMP and ICH requirements
7. Project management experience preferred.
8. Innovative spirit and consciousness
9. Communication skills, Fluency in English and Mandarin
Shanghai Johnson & Johnson Pharmaceuticals, Ltd. (7048)