R&D Manager (ผู้จัดการฝ่ายวิจัยและพัฒนา)

หน้าที่และความรับผิดชอบ

• • Proactively and effectively lead R&D teams; formulators and R&D analysts, through the effective planning and execution of drug development process of immediate release and modified release tablet and capsule dosage form, and R&D initiatives. • Ensure the project management in alignment with the established organizational objectives • Develop robust formulations and processes, scale-up and optimize the 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 millstones and SOPs, as well as relevant documentation and test results for accuracy and completeness and compliance with SOPs/GMP requirements. • Review of batch records, process characterization reports, validation reports and investigation reports. • 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. • 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

คุณสมบัติ

คุณสมบัติด้านความรู้และความสามารถ

• • Male and Female, Age 35 - 50 years old • Bachelor 's or Master's degree in Pharmacy, Industrial Pharmacy. • 10+ years of experience in manufacturing pharmaceuticals. • 5+ years of experience as R&D Manager position. • Knowledge of PIC/s GMP and quality requirements related to pharmaceuticals including ICH, ASEAN Guideline. • Must be proficient in computer skills & software applications such as Microsoft Office tools. • Must be able to work under minimal supervision and able to work independently and in a team environment. • Must possess strong documentation and technical writing skills; and able to apply relevant scientific principles and practices. • Good communication Skills, Leadership Skills and Strategic Thinking Skills. • Good command of English Language.

สวัสดิการ

• ประกันสังคม
• ทำงานสัปดาห์ละ 5 วัน
• ประกันชีวิต
• ตามข้อตกลงของบริษัท
• สิทธิการเบิกค่าทันตกรรม

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