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Fda Project Jobs in Virginia (NOW HIRING)

Mirion Technologies

Continuous Improvement Manager

Norfolk, VA · On-site

$82.20K - $110.40K/yr

Ensure improvement projects support and strengthen compliance with FDA regulations (21 CFR Part 820), ISO 13485, and internal QMS requirements. * Partner with Quality teams to reduce defect rates ...

FAREVA

Facilities Supervisor

Henrico, VA

... FDA, OSHA, and EPA requirements. The Supervisor drives continual improvement of facilities systems, manages projects that support new business and site expansion, and ensures compliance with ...

Mirion

Continuous Improvement Manager

Norfolk, VA · On-site

$91.40K - $122.90K/yr

Ensure improvement projects support and strengthen compliance with FDA regulations (21 CFR Part 820), ISO 13485, and internal QMS requirements. * Partner with Quality teams to reduce defect rates ...

Granules

EHS Manager (GMP experience required)

Chantilly, VA · On-site

$85.80K - $116.30K/yr

Ensure compliance with OSHA, FDA, EPA, GMP , and applicable state and local regulations * Lead site ... and project. * Support GMP environments by ensuring safe manufacturing practices without ...

Intellectt INC

Quarantine Specialist

Manassas, VA · On-site

Ensure operations comply with SQF, HACCP, FQP, FDA, and cGMP standards. Verify that dietary ... Support special quality projects as assigned. Participate in all required training programs.

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Fda Project information

What are the key skills and qualifications needed to thrive as an FDA Project Manager, and why are they important?

To thrive as an FDA Project Manager, you need a strong background in regulatory affairs, project management, and a degree in life sciences or a related field. Familiarity with FDA submission requirements, electronic common technical document (eCTD) systems, and project management tools like MS Project or Asana is essential. Excellent communication, organization, and problem-solving abilities help manage cross-functional teams and ensure compliance. These skills ensure that projects meet regulatory standards, progress efficiently, and achieve timely FDA approvals.

What are some common challenges faced by professionals working on FDA project teams?

Professionals working on FDA project teams often encounter challenges related to regulatory compliance and shifting guidelines. Navigating complex documentation requirements, coordinating with cross-functional teams (such as clinical, regulatory, and quality assurance), and meeting strict submission deadlines are all common hurdles. Effective communication and adaptability are essential, as projects frequently involve collaboration across departments and ongoing updates based on regulatory feedback. Successfully managing these challenges helps ensure product approval and supports career advancement within regulatory affairs.

What is an FDA Project?

An FDA Project typically refers to a project that involves compliance with the U.S. Food and Drug Administration (FDA) regulations. These projects can include developing, testing, or bringing to market medical products such as drugs, medical devices, biologics, or food items. The goal of an FDA Project is to ensure that products meet safety, efficacy, and quality standards set by the FDA before they are approved for public use. Such projects often require extensive documentation, clinical trials, and regulatory submissions to obtain FDA approval.

What is the difference between Fda Project vs Fda Reviewer?

AspectFda ProjectFda Reviewer
Required CredentialsTypically requires a background in life sciences, engineering, or related fields; often includes project management certificationsRequires a degree in life sciences, pharmacy, or medicine; often needs FDA-specific training or experience
Work EnvironmentProject teams within pharmaceutical or biotech companies, regulatory agencies, or consulting firmsRegulatory agencies, pharmaceutical companies, or biotech firms reviewing submissions
Employer & Industry UsageUsed in project management contexts to oversee regulatory submissions and complianceUsed in regulatory review processes to evaluate drug, device, or food applications

In summary, Fda Project roles focus on managing regulatory initiatives and ensuring compliance within organizations, while Fda Reviewers are responsible for evaluating and approving submissions directly for regulatory approval.

What are popular job titles related to Fda Project jobs in Virginia? For Fda Project jobs in Virginia, the most frequently searched job titles are:
What job categories do people searching Fda Project jobs in Virginia look for? The top searched job categories for Fda Project jobs in Virginia are:
What cities in Virginia are hiring for Fda Project jobs? Cities in Virginia with the most Fda Project job openings:
Fda Project jobs near you

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

Granules

Chantilly, VA • On-site

Full-time

Posted 15 days ago

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.