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Fda Scientist Jobs in Silver Spring, MD (NOW HIRING)

DCG

Social Scientist

Baltimore, MD · Remote

Food and Drug Administration (FDA). This position will contribute to the design, implementation, analysis, and reporting of qualitative and quantitative social science research projects focused on ...

DCG

Social Scientist

Washington, DC · Remote

Food and Drug Administration (FDA). This position will contribute to the design, implementation, analysis, and reporting of qualitative and quantitative social science research projects focused on ...

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All JobsFda Scientist JobsFda Scientist Jobs in Silver Spring, MD

Fda Scientist information

See Silver Spring, MD salary details

$52.2K

$115.1K

$142.1K

How much do fda scientist jobs pay per year?

As of Aug 21, 2026, the average yearly pay for fda scientist in Silver Spring, MD is $115,104.00, according to ZipRecruiter salary data. Most workers in this role earn between $97,700.00 and $141,600.00 per year, depending on experience, location, and employer.

What is an FDA Scientist?

An FDA Scientist is a researcher or regulatory expert responsible for evaluating the safety, efficacy, and quality of pharmaceutical drugs, medical devices, biologics, and food products. They conduct laboratory research, review clinical trial data, and assess regulatory submissions to ensure compliance with federal laws and guidelines. FDA Scientists play a critical role in protecting public health by making science-based decisions on product approvals and safety standards.

What types of projects and responsibilities can I expect as an FDA Scientist?

As an FDA Scientist, you'll typically be involved in reviewing data from clinical trials, conducting laboratory research, evaluating the safety and efficacy of pharmaceuticals or medical devices, and preparing reports for regulatory submissions. You'll collaborate closely with multidisciplinary teams including chemists, statisticians, and regulatory specialists to ensure scientific rigor and adherence to federal standards. Some days may involve detailed data analysis, while others could require participating in cross-team meetings or interacting with external stakeholders. This dynamic environment offers opportunities to contribute to important public health decisions and develop specialized expertise over time.

What are the key skills and qualifications needed to thrive in the FDA Scientist position, and why are they important?

To thrive as an FDA Scientist, you need a solid background in biology, chemistry, pharmacology, or a related scientific field, typically supported by at least a bachelor's or advanced degree. Familiarity with regulatory submission systems, laboratory information management systems (LIMS), and relevant certifications such as Good Laboratory Practice (GLP) or Good Clinical Practice (GCP) is important. Strong analytical thinking, attention to detail, and effective communication skills help you excel when collaborating with colleagues and presenting findings. These abilities ensure accurate data review and regulatory compliance, which are crucial for advancing public health and safety.

How much do FDA scientists make?

FDA scientists typically earn between $70,000 and $130,000 annually, depending on experience, education, and location. Entry-level positions often start around $70,000, while experienced scientists with advanced degrees can earn higher salaries, especially in supervisory or specialized roles.

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For Fda Scientist jobs in Silver Spring, MD, the most frequently searched job titles are:

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What cities near Silver Spring, MD are hiring for Fda Scientist jobs?

Cities near Silver Spring, MD with the most Fda Scientist job openings:

Fda Scientist jobs near you
Infographic showing various Fda Scientist job openings in Silver Spring, MD as of August 2026, with employment types broken down into 1% As Needed, 84% Full Time, 12% Part Time, 2% Contract, and 1% Nights. Highlights an 87% Physical, 3% Hybrid, and 10% Remote job distribution, with an average salary of $115,104 per year, or $55.3 per hour.

Formulation Scientist (Solid Orals)

Granules Pharmaceuticals

Chantilly, VA • On-site

$100K - $110K/yr

Full-time

Re-posted 8 days ago

Job description

Job Type
Full-time
Description
Granules Pharmaceuticals Inc., (GPI) is a subsidiary of Granules India LTD. Over the past 34 years, we have worked towards strengthening our core and we are currently the 10th fastest growing generic pharma company in the US!
With our sites in Chantilly and Manassas, Virginia, we have R&D through manufacturing and packaging of our medicines including pulsatile drug release in tablet and capsule dosage form, orally disintegrating modified release tablets (XR, MR, ER), modified release suspension and controlled substances capabilities in an abuse deterrent technology platform.
We are dedicated to excellence in manufacturing, quality, and commercialization of generic drugs to give customers reliable and affordable options.
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
  • 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.
We believe in fair and transparent pay practices. Actual compensation is determined based on relevant experience, qualifications, skills, and internal equity.
Salary Description
$100,000 - $110,000 per year

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