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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