Research and Development (R&D) department is a crucial department of a pharmaceutical industry. As a R&D scientist a lot of technical functions are to be performed. In this article we mention few major activities of a R&D scientist:
- Operate as the subject matter expert (SME) on pre-formulation and formulation, process development and technology transfer as applied to solid, liquid, sterile injectable / parenteral formulations. Products may range from vials, ampoules, infusion bags, pre-filled syringes, tablets, capsules, eye drops etc.
- Lead formulation and process development, product characterization, process analytical technologies (PAT) and incorporation of active pharmaceutical ingredients (APIs), excipients, packaging material and devices to develop finished products. Products may range from internal product development projects, products that are commercialized, products that are in-licensed from external entity or products that are co-developed with a development partner.
- Conduct API, excipient, packaging or device characterization; excipient compatibility and forced degradation studies. Recommend stage appropriate acceptance criteria for vendor and regulatory specifications. Utilize relevant theoretical modeling and statistical tools, as required.
- 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., Commercial Operations, 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.
- Act as single-point technical contact for contract development and manufacturing organizations (CDMOs) or contract research organizations (CROs). Collaborate with project management (PM) function to lead execution of activities against approved plan.
- Provide relevant subject matter expertise in collaboration with external partners in the form of participation in technical strategy discussions; consultation on technical studies; hands-on characterization and/or third-party interface (e.g., CDMOs, CROs etc.)
- Draft high-quality industry standard technical documents (protocols, reports, technical memorandums, position papers etc.).
- Lead and/or participate in conducting data and hypothesis driven investigations for quality events (planned and unplanned deviations) with recommendations of relevant corrective and preventative actions (CAPAs) to line functions.
- 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 505(b)(1), 505(b)(2) or 505(j) submissions. Lead studies in support of responses to United States Federal Drug Administration (FDA) information requests or deficiency letters for various dossiers.
- Train peers and junior staff members on new techniques.
Typical Day-to-Day Activities
- New product development
- R&D activities such as pre-formulation, formulation, process development or analytical method development
- Primary Packaging development and optimization
- Technical Troubleshooting
- Technology Transfer
- Process Validations
- Leading activities at CDMOs
- Drafting dossier supportive documents
- Drafting and responding to relevant requests from the US FDA or EU authorities
- Working with external partners on technical activities
