R&d Manager

17 hours ago

Thailand Talentvis Full time

**Requirements:Qualification**
- Doctor'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 able to work under mínimal supervision and able to work independently and in a team environment.
- Good communication skills, leadership skills and strategic thinking skills.
- Good command of English Language.

**Responsibilities:Key Responsibility**
- Proactively and effectively lead R&D teams, formulators and R&D analysts, through the effective planning and execution of drug development process 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.
- 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

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