Solid Dosage Principal Scientist

Job Summary

• 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, e.g. project planning and timelines, experimental design, data evaluation, formulation of relevant and scientifically based conclusions, coordinates studies with other technical groups (e.g. 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.

Principle Accountabilities

• Developing complex 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 pace 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.

Management Responsibility 

The Principal 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 management.

Reports to

Sr. Vice President, R&D

Requirements

Knowledge & Skills 

Good communication skills, critical thinking, flexibility, time management, self-motivation.

Experience & Education

Ph.D. in pharmaceutical sciences with minimum of 5 year experience or Master’s in pharmaceutical sciences with minimum of 8 year experience in generic product development, with emphasis in solid/liquid orals or an equivalent combination of education and experience. 

Physical Requirements/Working Environment

May require little heavy lifting.

Travel 

No travel required.

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