หน้าที่ความรับผิดชอบ

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.

• 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.

• 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.