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Fda Investigator Jobs in Delaware (NOW HIRING)

Hologic, Inc.

Product Quality Engineer 1

Newark, DE · On-site

$54.90 - $86/hr

Active participation in internal and external audits, including but not limited to facility and supplier audits and Notified Body and FDA inspections * Supports monthly Quality Investigation Review ...

Hologic

Product Quality Engineer 2

Newark, DE · On-site

$78K - $122K/yr

Active participation in internal and external audits, including but not limited to facility and supplier audits and Notified Body and FDA inspections * Supports monthly Quality Investigation Review ...

Hologic Inc.

Product Quality Engineer 2

Newark, DE · On-site

$78K - $122K/yr

Active participation in internal and external audits, including but not limited to facility and supplier audits and Notified Body and FDA inspections * Supports monthly Quality Investigation Review ...

Hologic

Product Quality Engineer 1

Newark, DE · On-site

$54K - $86K/yr

Active participation in internal and external audits, including but not limited to facility and supplier audits and Notified Body and FDA inspections * Supports monthly Quality Investigation Review ...

Hologic Inc.

Product Quality Engineer 1

Newark, DE · On-site

$54K - $86K/yr

Active participation in internal and external audits, including but not limited to facility and supplier audits and Notified Body and FDA inspections * Supports monthly Quality Investigation Review ...

Hologic

Product Quality Engineer 2

Newark, DE · On-site

$78K - $122K/yr

Hands-on experience in complaint investigations, root cause analysis, and CAPA activities. * Familiarity with internal and external audits, including Notified Body and FDA inspections. Why join ...

Hologic Inc.

Product Quality Engineer 2

Newark, DE · On-site

$78K - $122K/yr

Hands-on experience in complaint investigations, root cause analysis, and CAPA activities. * Familiarity with internal and external audits, including Notified Body and FDA inspections. Why join ...

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All JobsFda Investigator JobsFda Investigator Jobs in Delaware

Fda Investigator information

See Delaware salary details

$32K

$75.4K

$131.1K

How much do fda investigator jobs pay per year?

As of Sep 5, 2026, the average yearly pay for fda investigator in Delaware is $75,389.00, according to ZipRecruiter salary data. Most workers in this role earn between $52,500.00 and $98,600.00 per year, depending on experience, location, and employer.

What does an FDA Investigator do?

An FDA Investigator is responsible for inspecting facilities that manufacture, process, or distribute regulated products, including food, drugs, medical devices, and cosmetics. They ensure compliance with federal regulations, identify violations, and document findings through reports. Investigators may also collect samples, review records, and participate in enforcement actions when necessary. Their work helps protect public health by ensuring the safety, efficacy, and quality of products entering the market.

What does a typical day look like for an FDA Investigator?

A typical day for an FDA Investigator involves conducting on-site inspections of food, drug, medical device, or cosmetic manufacturers to ensure compliance with federal regulations. Investigators review production processes, collect samples, examine records, and interview facility staff to assess safety and quality standards. The role often includes significant report writing and follow-up activities to document findings and recommend corrective actions. While much of the work is independent, FDA Investigators also collaborate closely with colleagues, regulatory officials, and industry representatives to resolve issues and maintain public health standards.

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

To thrive as an FDA Investigator, you need a background in science or public health, strong analytical skills, and often a bachelor's degree in a related field. Familiarity with regulatory databases, laboratory sampling equipment, and federal inspection protocols is typically required. Effective communication, meticulous attention to detail, and strong organizational skills help investigators excel in documenting findings and interacting with diverse stakeholders. These attributes are crucial for ensuring compliance with federal regulations and protecting public health.

How much money do FDA investigators make?

FDA investigators typically earn a median annual salary of around $70,000 to $90,000, depending on experience, location, and level of education. Entry-level investigators may start at lower salaries, while those with advanced certifications or extensive experience can earn higher wages, often with benefits such as health insurance and retirement plans.

How to become an FDA investigator?

To become an FDA investigator, candidates typically need a bachelor's degree in a relevant field such as biology, chemistry, or pharmacy, along with experience in regulatory or scientific work. They must also pass the FDA's specialized training program and meet background check requirements. Strong analytical skills, attention to detail, and knowledge of regulatory guidelines are essential for this role.

What are popular job titles related to Fda Investigator jobs in Delaware?

For Fda Investigator jobs in Delaware, the most frequently searched job titles are:

What job categories do people searching Fda Investigator jobs in Delaware look for?

The top searched job categories for Fda Investigator jobs in Delaware are:

Fda Investigator jobs near you
Infographic showing various Fda Investigator job openings in Delaware as of August 2026, with employment types broken down into 89% Full Time, and 11% Part Time. Highlights an 93% Physical, 1% Hybrid, and 6% Remote job distribution, with an average salary of $75,389 per year, or $36.2 per hour.

Principal Investigator / Sr. Principal Investigator, Clinical Pharmacology & Pharmacometrics

Incyte Corporation

Wilmington, DE • On-site

Other

Re-posted 22 hours ago

Job description

Overview

A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology, Oncology and Inflammation and Autoimmunity

Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.

Job Summary (Primary function)

We are seeking a Clinical Pharmacologist with expertise in Physiologically Based Pharmacokinetic (PBPK) modeling within the Clinical and Quantitative Pharmacology (CQP) organization in Transaltional Medicine. In this role, You will play a crucial role in leading and overseeing the clinical pharmacology activities on project teams. You will be responsible for providing, scientific leadership, and collaborative working environment to advance the drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders including quantitative pharmacology, in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs. You will also serve as the PBPK subject matter expert, partnering closely with, Clinical Development, DMPK, Drug Discovery, Pharmaceutical Sciences, Translational Medicine, Biometrics, Regulatory Affairs, and Drug Safety to inform critical development decisions. Your work will influence dose selection, formulation strategy, drug-drug interaction risk assessment, organ impairment strategy, pediatric extrapolation, and regulatory submissions throughout the development lifecycle.

How you will contribute:

  • Develop and implement the CP strategies across program, indication and study levels, including strategies for Phase I -III drug development.
  • Provide guidance in interpreting the data from quantitative pharmacology analyses, including PPK, exposure-response analyses, and other quantitative analyses, to drive MIDD based decision making for different phases of clinical development; provide justification for dose selection for pivotal clinical trials..
  • Provide the clinical pharmacology components of clinical plans and provide clinical pharmacology expertise to the project team.
  • Liase closely with biologists, DMPK, Pharmaceutical Sciences, Clinical Pharmacology, Translational Medicine, and Clinical Development to answer key mechanistic questions through innovative study designs and/or analyses.
  • Present data and recommendations to global program teams, external collaborators and senior management.
  • Build, verify, qualify, and apply PBPK models using platforms such as Simcyp, GastroPlus, PK-Sim, or equivalent software.

  • Integrate in vitro ADME, physicochemical, preclinical, and clinical data to develop mechanistic understanding of drug disposition.

  • Design and build PBPK and mechanistic models to assist with safety margin selection, study design and biomarker selection, including (but not limited to) first in human (FIH) predictions, formulation design/optimization, population simulations, pediatric extrapolation, and DDI predictions. Knowledge in DDI is a must.

  • Interpret modeling results and communicate recommendations to multidisciplinary teams and senior leadership.

  • Author PBPK reports, regulatory documents, briefing books, and responses to health authorities.

  • Stay current with scientific advancements and regulatory trends in clinical pharmacology and Pharmacometrics, and apply the knowledge to advance drug discovery and development for the organization;

  • Publish in peer reviewed journals. Present work internally and externally through scientific communications and conference presentations.

Minimum Requirements/Qualifications:

  • Ph.D. or MD with 3 to 10 years or more of experience in appropriate disciplines that lay the foundation for the job functions detailed above;
  • Prior successful experiences on clinical development teams delivering enabling clinical PK and clin pharm analyses
  • Excellent communication skills and ability to effectively collaborate with cross-functional teams and influence decision-making process;
  • Strong competency in learning and running PBPK modeling and simulation related software such as GastroPlus, SimCyp, PKSim, R and Matlab/SimBiology.
  • Hands-on project experience in PBPK modeling and simulation through direct industry experience as well as knowledge of regulatory expectations regarding PBPK modeling is preferred.
  • Preferred hands on experience with PPK, ER or PBPK analyses and reporting, and experience using NONMEM, R, SimCYP or GastroPlus, or other programs.
  • Direct pharmaceutical or biotechnology industry experience supporting clinical development programs.
  • Experience interacting with FDA, EMA, PMDA, or other regulatory agencies regarding PBPK analyses.
  • Experience with model-informed drug development (MIDD).
  • Demonstrated a general understanding of general DMPK disciplines: in vitro ADME, pharmacokinetics, transporter, DDI, translational modeling, biotransformation, biomarker strategy is a plus
  • Demonstrated publication record; lead/senior author contributions is a plus
  • Ability to prioritize and manage multiple projects while meeting project deadlines.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

We Respect Your Privacy

Learn more at: http://www.incyte.com/privacy-policy

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.

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