RD Officer

- Make an overall plan for a whole product development process.- Study and translate technical documents related to a specific product development.- Refer to information of reference product (innovator or branded product) and propose specifications for raw materials and finished product (if needed).- Request QC department to establish specifications and/or analytical procedures for raw materials and finished product; request QV department to execute analytical method validation (if needed).- Prepare protocol for a development process for each specific product.- Request L&P department to provide raw materials (APIs, excipients, packaging materials) needed for the product development process as per the proposed specifications.- Request QC department to perform testing of raw materials for production of trial and scale- up batches.- Prepare manufacturing process for trial and scale- up batches.- Cooperate closely with other departments to schedule and execute trial batches, scale- up batches and formulation optimization as per the established protocol.- Request QC department to perform testing of finished product, comparative dissolution profiles and stability study including stress testing.- Prepare manufacturing process for pilot scale batches.- Cooperate with QV department to prepare manufacturing process validation protocol for pilot scale batches.- Join in manufacturing process validation on pilot batches.- Cooperate with QV department to prepare manufacturing process report on pilot batches.- Request QC department to perform testing of finished product, comparative dissolution profiles and BE study (where required), stability study.- Perform an overall evaluation of the project from trial batches till pilot batches until a confirmation of a success is obtained.- Prepare manufacturing process and manufacturing process validation protocol for production batches.- Write completely pharmaceutical development section for the submission for product registration under the guidance of RA Manager.- Provide RA staffs with documentation and the study data for product registration.- Transfer the manufacturing process from pilot batches to production batches with the assistance of other departments.- Involved in the investigation of causes and deal with problems during the transfer of manufacturing process to production.- Improve formulation and manufacturing process (where needed).- Update the specialist knowledge, current requirements, regulation and guidelines.- Perform any other tasks as per assigned by RA Manager.- Prepare weekly, monthly and quarterly reports on the project progress.

- Bachelor’s degree: Pharmacy, Chemistry, Biology, Chemical Engineering.- 1- 2 years of experience within the pharmaceutical industry and especially in R&D.- Good health.- Ability to work collaboratively in a team.- Good level of knowledge in written and spoken English and computer literacy.- Ability to travel.

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Cập nhật gần nhất lúc: 2026-01-14 21:00:04