Granules Pharmaceuticals, Inc. · 1 month ago
Formulation Scientist/Sr. Scientist, R&D (Solid Orals)
Chantilly, VA
Full-time
Onsite
Mid, Senior Level
2+ years expGranules Pharmaceuticals, Inc. is focused on product development in the pharmaceutical industry. The Formulation Scientist/Senior Scientist will manage and execute projects related to the design and development of solid oral dosage forms, ensuring compliance with regulatory standards and leading cross-functional teams.
Pharmaceuticals
Responsibilities
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
Qualification
Required
Ph.D. in pharmaceutical sciences with minimum of 2 years' experience OR
Masters in pharmaceutical sciences with minimum of 5 years' experience in generic product development, with emphasis in solid/liquid orals or an equivalent combination of education and experience
Good communication skills
Critical thinking
Flexibility
Time management
Self-motivation
Company
Granules Pharmaceuticals, Inc.
Granules Pharmaceuticals, Inc. is a pharmaceuticals company based out of 3701 CONCORDE PKY, Chantilly, Virginia, United States.
Founded in 2014Chantilly, Virginia, US
51-200 employeesH1B Sponsorship
Granules Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (49)
2024 (7)
2023 (22)
2022 (24)
2021 (10)
2020 (19)
Funding
Current Stage
Growth StageLeadership Team
Gregory B. Reeves
Chief Human Resources Officer
Company data provided by crunchbase