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R&d Supervisor
2 weeks ago
Requirements:Qualification
- Doctor's or Master's degree in Pharmacy, Industrial Pharmacy
- 3+ years of experience in manufacturing pharmaceuticals
- Have experience in R&D and formulation section
- Knowledge of PIC/S GMP and quality requirements related to pharmaceuticals including ICH, ASEAN Guideline.
- Good command over written and verbal English.
- Be able to work under mínimal supervision and able to work independently and in a team environment.
- Knowledge of statistical analysis
**Responsibilities:Job Summary**
- New product development
- R&D activities such as pre-formulation, formulation, process development
- Technical Troubleshooting
- Technology Transfer
- Process Validation
- Drafting dossier supportive documents
**Key Responsibility**
- Formulation scientist with experience in formulation, pre-formulation & physical pharmacy.
- The R&D Scientist position is an individual contributor role and reporting to a Manager or Technical Director.
- 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.
- 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 Food and Drug Administration (Thai FDA) information requests or deficiency letters for various dossiers.
