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

Description

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

• Developing pharmaceutical products, leading to successful ANDA filings and approval in a timely manner.
• Managing and scheduling multiple projects, setting objectives, prioritizing activities to meet the milestones in a fast-paced environment.
• Designing, formulation and process development for various drug from project initiation to commercialization by following appropriate GMP regulations and safety requirements.
• Participate in the set-up and operation of pilot scale equipment and instrumentation for the completion of small production runs in collaboration with the R&D technician.
• Design and conduct pre-formulation and formulation studies, process development and optimization of prescription dosage form designs and ANDA oral Dosage forms using DOE
• Perform Literature search and Evaluate patents to develop non-infringing strategies
• Preparation of product manufacturing, batch records and protocols for different product development stages, including from R&D prototype formulations to process validations following SOPs and procedures, ensuring the detailed record and data keeping.
• Utilize formulation techniques, processing equipment and unit operations including Wurster Coating, Tablet Coating, Compression, Blending, Encapsulation, HPLC, Spectrophotometry, Dissolution, Viscometer to develop Bio-Equivalent products
• Review Analytical Data, draft SOP’s, Process Evaluation protocols, IQ, OQ, PQ protocols and GMP Manufacturing Batch records, Packaging Batch Records.
• Characterization of APIs, excipients and in process products; analysis of in-process samples or in-process products based on protocols and QbD concept, preparing various formulation samples to support cross-functional programs as needs.
• Completes documentation associated with manufacturing processes (e.g. batch record, protocols, and logbooks) with detail and accuracy.
• Establishing documentation management systems for CMC development and meeting FDA GMP, regulatory requirement, and FDA onsite inspections.
• Comprehensive knowledge of IVIVC, QbD and Design of Experiments (DOE).
• Ensuring all regulatory documents in compliance with SOPs, FDA Regulations, and cGMP policy where applicable.
• Knowledge of manufacturing regulatory programs and objectives (cGMP, CFR 210 and 211).
• Maintaining compliance with GMP, SOPs and DEA regulations.
• Coordinate with Regulatory Affairs, Operations, QC/QA and Supply Departments to ensure that projects are planned and executed in a timely manner.