Pharmaceutical & Medical Services
28 Apr 2022
Job Opportunity: R&D Manager (120K)
Position
R&D Manager (120K)
Our Client
A Pharmaceutical Company
Location
Samut Sakon
Report to
Managing Director
Job Scope:
- 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 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.
- 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
Qualifications:
- Bachelors or Master's degree in Pharmacy, Industrial Pharmacy.
- 10+ years of experience in manufacturing pharmaceuticals.
- 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.
- Good command of English Language.