Johnson & Johnson Careers
Senior Scientist Self Care R&D
Requisition ID: 1805660966W
• Act as project lead for Asia-Pacific innovation projects. Work with cross functional team to design product per specific business strategies.
• 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.
• 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.
• Actively interact with QA, Supply Chain, Medical & Regulatory Affairs teams to ensure effective technology transfer.
• Be responsible for the drafting of pharmaceutical section within application dossier for new product, assist IND/NDA submission.
• Manage projects and ensure development milestones are reached on time within target.
• Manage external institutions, CROs, and technology development companies to ensure smooth project execution.
• Support the BD team with potential technical due diligence work. Provide technical assessments on potential M&A deals.
• A minimum of Master Degree in Medicine Pharmaceutics, or Chemistry related fields.
• At least 3 years (Doctor) or 5 years (Master) of experience with OTC or Generic drug formulation Development and technical transfer.
• Knowledge and experience in oral liquid and solid formula and process design and development
• Knowledge and experience in oral liquid and solid products process validation (PV)
• Knowledge of QbD (Quality by Design) preferred
• Knowledge of Regulations and GMP requirements
• Project management experience preferred.
• Innovative spirit and consciousness
• Communication skills, Fluency in English and Mandarin
Shanghai Johnson & Johnson Pharmaceuticals, Ltd. (7048)