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

Granules Pharmaceuticals, Inc. –
Formulation Scientist/Sr. Scientist, R&D (Solid Orals)

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Job Type: Full-time

• 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 drugs 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.
• Prepare 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 detailed record‑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 SOPs, process evaluation protocols, IQ, OQ, PQ protocols and GMP manufacturing batch records, packaging batch records.
• Characterize APIs, excipients and in‑process products; analyze in‑process samples or products based on protocols and QbD concept, preparing various formulation samples to support cross‑functional programs as needed.
• Complete documentation associated with manufacturing processes (e.g., batch record, protocols and logbooks) with detail and accuracy.
• Establish documentation management systems for CMC development and meet FDA GMP, regulatory requirements, and FDA onsite inspections.
• Comprehensive knowledge of IVIVC, QbD and design of experiments (DOE).
• Ensure 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).
• Maintain 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.

The Senior Scientist leads the assigned projects and guides the operation of the product development ranging from selection of staff, choice of methods, purchase of equipment, quality assurance, quality control, safety, hours of operation, scheduling of staff, and utilization…