R&d Manager (Pharmacist)

Proactively and effectively lead R&D teams, formulators and R&D analysts, through the effective planning and execution of drug development processand R&D initiatives. - Ensure the project management in alignment with the established organizational objectives - Develop robust formulations and processes, scale-up and optimization of manufacturing process, execution of pre-exhibit and exhibit batches, scale up and technology transfer from R&D to production and to QC department to meet timelines and within budgets. - Plan and contribute to project-related scientific/technical activities (e.g., interpret results, critical assessment of data, draw relevant conclusions, and write reports). - Create and review product milestones and SOPs, as well as relevant documentation and test results for accuracy and completeness and compliance with SOPs/GMP requirement. - Effectively action and making decisions including issue managements for all R&D activities throughout scientific disciplines. - Work collaboratively with other cross-functional teams to execute product portfolios and change controls associated with manufacturing and packaging master records, SOPs, protocols and any other relevant documents. - Prepare documentation for regulatory purposes and coordinate with RA for drug dossier/variation filing and addressing deficiencies; provide relevant documents to RA in a timely manner for drug dossier/variation filing. - Develop robust lab-scale, pilot-scale and commercial-scale manufacturing process based on Quality by Design (QbD) principles using design of experiments (DOE). Recommend stage appropriate acceptance criteria. Utilize PAT where feasible. Utilize relevant statistical tools, as required. - Manage, review and challenge the project budget plan and track the expenses as needed. - Evaluate patents and develop non-infringement strategies. - Interaction with API manufacturers, CROs, CMOs and outsourcing product developers/ laboratories as needed. - Support other activities relevant to quality issues ประกันสังคม,โบนัส,เบี้ยขยัน,ชุดพนักงาน,กองทุนสำรองเลี้ยงชีพ ปริญญาตรี 10 ปีขึ้นไป Bachelors or Masters degree in Pharmacy, Industrial Pharmacy. 10+ years of experience in manufacturing pharmaceuticals. 5+ years of experience as R&D Manager position. นำเข้าและจำหน่ายยาและเวชภัณฑ์ทางการแพทย์