Formulation Scientist/Sr. Scientist, R&D (Solid Orals)
Company: Granules
Location: Chantilly
Posted on: February 16, 2026
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Job Description:
Job Description 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.
Keywords: Granules, Chantilly , Formulation Scientist/Sr. Scientist, R&D (Solid Orals), Science, Research & Development , Chantilly, Virginia
