ผู้จัดการฝ่ายวิจัยและพัฒนา-จ.เชียงใหม่
บริษัท แอตแลนต้า เมดดิคแคร์ จำกัด- 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
- 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.
- Work 6 days a week.
- กองทุนสำรองเลี้ยงชีพ
- การฝึกอบรมและพัฒนาพนักงาน
- ค่าที่พัก (ต่างจังหวัด)
- ค่าน้ำมันรถ, ค่าเดินทาง
- ค่ายินดีมงคลสมรส
- ค่าอนุโมทนาอุปสมบท
- ค่าเบี้ยเลี้ยง
- ค่าโทรศัพท์
- ประกันสังคม
- ประกันอุบัติเหตุ
- ลาบวช
- เครื่องแบบพนักงาน, ชุดยูนิฟอร์ม
- เงินช่วยเหลือฌาปนกิจ
- เที่ยวประจำปี หรือเลี้ยงประจำปี
- เบี้ยขยัน, ค่าตอบแทนพิเศษ
- โบนัสประจำปี
The First Choice Marketing Partner for the Leading Global Pharmaceutical, Biotech, Medical Devices & Diagnostics companies to make a connect with Medical & Pharmaceutical Fraternity in Thailand
To serve the Thai Population with the Best Treatment available in the World
ไฮไลท์เด่นของงาน
- โรงงานปลูกและสกัดกัญชาในทางการแพทย์
- ปฏิบัติงานที่ อ.แม่แตง จ.เชียงใหม่