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Fresenius Medical Care

Stability Scientist I

Ogden, UT · On-site

Works closely with the Stability Scientist II on stability-related issues/projects. * Maintains general housekeeping of working area, environmental chambers and proximal plant areas. * Builds stable ...

Merck Group

Scientist 2 - Stability

Rockville, MD · On-site

$71K - $132K/yr

As a Stability Scientist 2, your activities will support stability programs for a wide set of clients spanning diverse types of drug substances, drug products, intermediates and critical raw ...

Moderna, Inc.

Director, CMC Stability

Norwood, MA · On-site

To be successful, you will bring strong CMC judgment, deep stability science, and the ability to make practical trade-off decisions in a fast-paced, matrixed environment. You will help teams evaluate ...

Moderna Therapeutics

Director, CMC Stability

Norwood, MA · On-site

$167 - $300.70/hr

To be successful, you will bring strong CMC judgment, deep stability science, and the ability to make practical trade-off decisions in a fast-paced, matrixed environment. You will help teams evaluate ...

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Stability Scientist information

What is the difference between Stability Scientist vs Analytical Chemist?

AspectStability ScientistAnalytical Chemist
Required CredentialsBachelor's or Master's in Chemistry, Pharmaceutical Science, or related field; often certifications in stability testingBachelor's or Master's in Chemistry, Analytical Chemistry, or related field; certifications in analytical methods
Work EnvironmentLaboratories focused on stability testing, pharmaceutical or biotech industriesAnalytical labs, quality control, research and development in various industries
Employer & Industry UsagePharmaceutical, biotech, and cosmetic companies conducting stability studiesManufacturers, research labs, quality assurance in multiple sectors

While both Stability Scientists and Analytical Chemists work in laboratory settings and require chemistry backgrounds, Stability Scientists specialize in testing product stability over time, ensuring shelf life and storage conditions. Analytical Chemists focus on analyzing chemical compositions and developing testing methods. The roles often overlap, but Stability Scientists are more involved in long-term stability studies specific to product safety and efficacy.

What is the role of a stability scientist?

A stability scientist is responsible for evaluating the stability of pharmaceutical products over time to ensure their safety, efficacy, and quality. They design and conduct stability studies, analyze data, and develop storage conditions, often using tools like statistical software and following regulatory guidelines such as ICH standards.
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Infographic showing various Stability Scientist job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 84% Full Time, 10% Part Time, and 5% Contract. Highlights an 97% Physical, 1% Hybrid, and 2% Remote job distribution.

Stability Scientist I

Fresenius Medical Care

Ogden, UT • On-site

Full-time

Posted 11 days ago

Fresenius Medical Care rating

6.8

Company rating: 6.8 out of 10

Based on 1,325 frontline employees who took The Breakroom Quiz

490th of 887 rated healthcare providers

Job description

PURPOSE AND SCOPE:
Coordinates stability programs and facilities. Reviews for completeness, verifies and enters stability data into the stability database when received from the QS Laboratory Groups. Assists in laboratory quality and validation projects including special analyses and stability studies.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
  • Reviews notes and test methods and compare information with final reports to detect errors and ensure completeness and conformity to SOPs and regulatory guidance.
  • Coordinates drug and device stability studies. Coordinates stability chamber space and environmental conditions, including product levels and mechanical maintenance.
  • Maintains data base and spreadsheets.
  • Assists the drug/device laboratories with stability testing using various techniques as required by respective projects based on current training and capabilities.
  • Compares input and output data and calculations for correctness.
  • Assists in stability study maintenance projects and laboratory quality improvement projects.
  • As required by stability SOP's and protocols, loads and pulls stability samples into/from the stability chambers. Delivers samples to the respective testing laboratories testing.
  • Gathers and reviews data related to stability testing and compiles into respective study files. Enters respective data into the stability database for review and approval.
  • Works closely with the Stability Scientist II on stability-related issues/projects.
  • Maintains general housekeeping of working area, environmental chambers and proximal plant areas.
  • Builds stable working relationships internally.
  • Normally receives specific, detailed instructions on all work.
  • May refer to senior staff, if applicable, for assistance with day-to-day problems that may arise.
  • Escalates issues to Stability Scientist II, supervisor or manager for resolution, as deemed necessary.
  • Assist with various projects as assigned by direct supervisor.
  • Other duties as assigned.

Drug Stability Duties
  • Coordinates drug stability studies.
  • Oversees drug product levels and inventories.
  • Compiles and submits Annual Drug Product Review data to respective ADPR team leaders.
  • Monitors drug environmental storage conditions. Assures proper environmental chamber operation and maintains environmental conditions.
  • Performs chamber reprofiles for drug chambers as required.
  • Assures annual (ongoing) stability lots are pulled and placed into stability yearly as specified in the applicable SOP.
  • Performs annual test method, instrument qualification and software validation reviews in accordance with the respective PM requirements.
  • Device Stability Duties
  • Coordinates device stability studies.
  • Oversees device product levels and inventories.
  • Provides device-related stability reports and data to respective study leaders as required.
  • Monitors device environmental storage conditions. Assures proper environmental chamber operation and maintains environmental conditions.
  • Performs chamber reprofiles for device chambers as required.
  • Performs annual test method, instrument qualification and software validation reviews in accordance with the respective PM requirements.

Additional responsibilities may include focusing on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
  • Regularly required to use hands and fingers to handle and talk or hear. Frequently required to stand; walk; sit; reach with hands and arms and wear personal protective equipment that may include Safety glasses, etc.
  • Occasionally required to climb or balance and stoop, kneel, crouch, or crawl.
  • Must frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.
  • Occasionally exposed to wet and/or humid conditions; moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals and risk of electrical shock.
  • The noise level in the work environment is usually moderate.

EXPERIENCE AND REQUIRED SKILLS:
  • Bachelor's degree in chemistry or closely related science field required
  • Minimum 1 - 2 years' stability or laboratory related experience.
  • Ability to read, analyze, and interpret general business periodicals, professional journals, science journals, technical procedures, or governmental regulations.
  • Strong oral and written communication skills.
  • Ability to apply advanced mathematical concept
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists
  • Proficient with PC operating systems, windows a plus
  • Experience in Microsoft Office applications.
  • Knowledge in cGMP, Drug and device processes a plus.

Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.
Fresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non-merit-based factors

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About Fresenius Medical Care

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We are a Team of more than 70,000 with one guiding Principle Patients First. This promise starts with providing the most comprehensive care for people living with Chronic Kidney Disease and extends to Innovative Solutions that are redefining Healthcare and setting the industry standard. From evolving home Dialysis and Patient education programs to improving patient care to providing World Class Research and Data driven insights. Our vertically integrated network tirelessly seeks new ways to improve the quality of our Patients' lives. We believe each of us can make an impact and together we can change an industry. Our Mission is to Provide Superior care that improves the quality of life of every patient, every day, setting the standard by which others in the Healthcare Industry are judged. And none of us does it alone. We bring together the brightest minds in kidney care to Dream, Research, and Innovate.

Industry

Health care and social assistance

Company size

10,000+ Employees

Headquarters location

Waltham, MA, US

Year founded

1996

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