Formulation Pharmacist with experience in formulation, pre-formulation & physical pharmacy.
The R&D Pharmacist position is an individual contributor role and reporting to a Manager.
Work as a subject matter expert (SME) on pre-formulation and formulation & process development or technology transfer or analytical sciences as applied to development, characterization, excipients, packaging material and devices to develop finished products. Products may range from internal product development projects, products that are commercialized.
Conduct API, excipient, packaging or device characterization; excipient compatibility.
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.
Review and analyze relevant stability data from lab-scale, pilot-scale and commercial-scale, R&D and GMP stability studies by utilizing industry standard modeling and analysis tools including regression analysis for shelf-life prediction. Develop and implement strategies to control related substances, where applicable.
Work with relevant cross-functional stakeholders (e.g., Production, Purchasing, Quality Control, Quality Assurance etc.) on scale-up and technology transfer of processes from R&D to commercial functions.
Lead and/or participate in activities related to process development, process verification / qualification, process pre-validation, process validation, site and equipment qualification in collaboration with relevant stakeholders.
Operate as the subject matter expert (SME) on analytical methods.
Draft high-quality industry standard technical documents (protocols, reports, technical memorandums, position papers etc.).
Independently draft and/or review standard operating procedures (SOPs).
Maintain effective and pro-active communication and coordination of activities with multi-functional stakeholders.
Draft and/or participate in drafting relevant sections of dossiers towards generic, innovative / super generic product submissions. Lead studies in support of responses to Thai Federal Drug Administration (TFDA) information requests or deficiency letters for various dossiers.
คุณสมบัติ
Bachelor's or Master's degree in Pharmacy, Industrial Pharmacy.
Must possess strong documentation and technical writing skills; and able to apply relevant scientific principles and practices.
Good command over written and verbal English.
Must be able to work under minimal supervision and able to work independently and in a team environment.
Must be proficient in computer skills & software applications such as Microsoft Office tools.
Knowledge of statistical packages is a plus.
No remote work available.
Must be willing to work some weekends based on a relevant business need, if required.
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
- กองทุนสำรองเลี้ยงชีพ
- การฝึกอบรมและพัฒนาพนักงาน
- ค่าที่พัก (ต่างจังหวัด)
- ค่าน้ำมันรถ, ค่าเดินทาง
- ค่ายินดีมงคลสมรส
- ค่าอนุโมทนาอุปสมบท
- ค่าเบี้ยเลี้ยง
- ค่าโทรศัพท์
- ประกันสังคม
- ประกันอุบัติเหตุ
- ลาบวช
- เครื่องแบบพนักงาน, ชุดยูนิฟอร์ม
- เงินช่วยเหลือฌาปนกิจ
- เที่ยวประจำปี หรือเลี้ยงประจำปี
- เบี้ยขยัน, ค่าตอบแทนพิเศษ
- โบนัสประจำปี
บริษัท แอตแลนต้า เมดดิคแคร์ จำกัด
เกี่ยวกับบริษัท
To be an Innovator in Thai Pharmaceutical Industry
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
ที่อยู่
9 Soi Ramindra 19 yaek 1, Anusawaree, Bangkean, Bangkok 10220