Formulation Scientist​/Sr. Scientist, R&D; Solid Orals

Formulation Scientist / Senior Scientist Job Summary

• Under general direction, manages, plans, and executes projects for product development.
• Under limited direction and supervision, designs and develops solid oral dosage forms using QbD concept for ANDA filing and/or product launch.
• Under limited direction and supervision, designs and develops complex oral dosage forms using QbD concepts for ANDA filing and/or product launch.
• Develops and executes formulation strategies related to product development (project planning, experimental design, data evaluation, and formulation of relevant and scientifically based conclusions).
• Coordinates studies with other technical groups (Analytical Sciences, Biopharmaceutics, Legal, Regulatory & Tech Services).
• Maintains a high level of expertise and develops new technologies and concepts for oral controlled release drug products.
• Participates as project leader, manager, or ad‑hoc member in Product Development efforts, identifying, analyzing, and suggesting corrective actions to optimize R&D processes, technology and regulatory compliance issues.

• Developing pharmaceutical products leading to successful ANDA filings and approvals in a timely manner.
• Managing and scheduling multiple projects, setting objectives, prioritizing activities to meet milestones in a fast‑paced environment.
• Designing, formulating, and process developing drugs from project initiation to commercialization following GMP regulations and safety requirements.
• Participating in the set‑up and operation of pilot‑scale equipment and instrumentation for small production runs with the R&D technician.
• Designing and conducting pre‑formulation and formulation studies, process development and optimization of prescription dosage form designs and ANDA oral dosage forms using DOE.
• Performing literature searches and evaluating patents to develop non‑infringing strategies.
• Preparing product manufacturing, batch records and protocols for different development stages, from R&D prototype formulations to process validations following SOPs, ensuring accurate documentation and data keeping.
• Utilizing formulation techniques, processing equipment and unit operations (Wurster Coating, Tablet Coating, Compression, Blending, Encapsulation, HPLC, Spectrophotometry, Dissolution, Viscometer) to develop bio‑equivalent products.
• Reviewing analytical data, drafting SOPs, process evaluation protocols, IQ, OQ, PQ protocols and GMP manufacturing batch records, packaging batch records.
• Characterizing APIs, excipients and in‑process products; analyzing in‑process samples using QbD concept, preparing formulation samples to support cross‑functional programs.
• Completing documentation associated with manufacturing processes with detail and accuracy.
• Establishing documentation management systems for CMC development and meeting FDA GMP, regulatory requirements, and FDA onsite inspections.
• Maintaining knowledge of IVIVC, QbD and DOE.
• Ensuring regulatory documents comply with SOPs, FDA regulations and cGMP policy.
• Coordinating with Regulatory Affairs, Operations, QC/QA and Supply Departments to ensure timely project execution.

The Senior Scientist leads the assigned projects and guides the operation of product development, from staff selection and method choice to equipment purchase, quality assurance, quality control, safety, scheduling and utilization management.

Sr. Vice President, R&D

• Ph.D. in pharmaceutical sciences with a minimum of 2 years’ experience or
• Master’s in pharmaceutical sciences with a minimum of 5 years’ experience in generic product development, emphasizing solid/liquid orals or an equivalent combination of education and experience.

• Good communication skills, critical thinking, flexibility, time management, and self‑motivation.