Formulation Scientist/Sr. Scientist, R&D (Solid Orals)

Granules Pharmaceuticals Inc.; Chantilly (VA); On-site; USD 80,000 - 110,000; Full time

Job summary

Granules Pharmaceuticals Inc. in Chantilly, Virginia, is seeking a Formulation Scientist/Senior Scientist to manage and execute projects for product development, including the design and development of solid oral dosage forms. The ideal candidate will hold a Ph.D. in pharmaceutical sciences or a Master's degree with substantial experience in generic product development.

The role involves coordination with various technical groups and ensuring compliance with regulatory requirements. Strong communication and critical thinking skills are essential for this position.

Qualifications

• Ph.D. in pharmaceutical sciences with minimum 2 years' experience or master's with minimum 5 years' experience in generic product development.
• Experience in solid/liquid orals or an equivalent combination of education and experience.

Responsibilities

• Manage and execute projects for product development.
• Design and develop complex oral dosage forms.
• Coordinate studies with other technical groups.
• Ensure all regulatory documents are in compliance.

Skills

Good communication skills

Critical thinking

Flexibility

Time management

Self-motivation

Education

Ph.D. in pharmaceutical sciences

Masters in pharmaceutical sciences

Tools

Wurster Coating

Tablet Coating

HPLC

Spectrophotometry

Viscometer

Job description

Description

Formulation Scientist/Senior 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 (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.

Principal Accountabilities

Job Duties & Responsibilities

• 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.

Management Responsibility

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 management.

Reports to

Sr. Vice President, R&D

Requirements

Minimum Requirements

Knowledge & Skills

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

Minimum Experience & Education

• Ph.D. in pharmaceutical sciences with minimum of 2 years' experience OR;
• Masters in pharmaceutical sciences with minimum of 5 year' experience in generic product development, with emphasis in solid/liquid orals or an equivalent combination of education and experience.

Disclaimer

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.