Associate Analytical Scientist - 238749

Medix™; East Windsor Township (NJ); On-site; USD 80,000 - 100,000; Full time

Job summary

Join a forward-thinking company as an Analytical Scientist, where you'll play a crucial role in ensuring the quality of pharmaceutical products. This position involves conducting and validating a variety of analytical tests, developing new methods, and leading investigations into laboratory results. You will collaborate closely with clients and internal teams, making your contributions vital to compliance and quality assurance. If you're passionate about science and eager to make an impact in the pharmaceutical industry, this opportunity is perfect for you.

Benefits

Medical insurance

Vision insurance

401(k) plan

Qualifications

• 2-4 years of analytical lab experience required.
• Strong expertise in cGMP and FDA standards.
• Excellent communication skills for internal and client interactions.

Responsibilities

• Conduct and validate analytical testing of various samples.
• Develop and implement new analytical methods.
• Lead investigations into Out-of-Specification results.

Skills

Analytical Testing

Method Development

cGMP Compliance

Data Interpretation

Communication Skills

Statistical Analysis

Education

Bachelor’s degree in Chemistry

Tools

HPLC

Microsoft Office

Job description

Get AI-powered advice on this job and more exclusive features.

This range is provided by Medix. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$32.00/hr - $38.00/hr

Position Summary

The Analytical Scientist is responsible for performing a wide range of tests to assess the quality of raw materials, in-process materials, finished products, and cleaning verification/validation samples to ensure compliance with established regulatory and company standards. This role leads analytical method development and validation activities, conducts both routine and non-routine testing, and plays a key role in laboratory investigations, documentation, and reporting. The position also serves as a technical liaison with clients, supporting method development, data interpretation, and investigative efforts.

Key Responsibilities:

• Conduct and validate analytical testing of raw materials, intermediates, finished products, environmental samples, and stability batches.
• Develop, validate, and implement new analytical methods, including those for cleaning verification (e.g., via HPLC).
• Author detailed analytical protocols, validation reports, and Certificates of Analysis.
• Troubleshoot analytical methods and laboratory equipment.
• Compile, interpret, and document analytical data following cGMP standards.
• Maintain accurate laboratory records including notebooks, worksheets, and batch records.
• Review and peer-check laboratory documentation for accuracy and compliance.
• Lead investigations into Out-of-Specification (OOS) and Out-of-Tolerance (OOT) results, and communicate findings per SOPs.
• Support environmental monitoring efforts as needed.
• Train and lead a team of analytical scientists and technicians.
• Ensure adherence to SOPs, cGMP, ICH, USP/EP, ISO, and regulatory guidelines (21 CFR Parts 210, 211, and 820).
• Interact with clients regarding laboratory activities, including method development and investigation outcomes.
• Perform other related duties as assigned.

Qualifications:

• Bachelor’s degree in Chemistry or a related scientific field.
• 2-4 years of analytical laboratory experience.
• Extensive knowledge of cGMP, FDA (21 CFR Parts 210, 211, 820), ICH, EU, and ISO standards.
• Strong expertise in pharmacopeial requirements (USP, EP, etc.).
• Experience in specialized testing such as dissolution or aerosol analysis is preferred.
• Proven ability to develop and validate complex analytical methods.
• Excellent written and verbal communication skills, including the ability to present findings internally and externally.
• Highly skilled in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Strong organizational skills, attention to detail, and manual dexterity.
• Ability to interpret and follow complex documents such as SOPs, protocols, and regulatory guidelines.
• Capable of clear and effective communication with internal teams and external clients.
• Proficient in applying arithmetic and basic statistical concepts to analytical processes.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research and Science

• Industries

  Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Medix by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Get notified when a new job is posted.

Sign in to set job alerts for “Analytical Scientist” roles.

North Brunswick, NJ $80,000.00-$110,000.00 2 weeks ago

Middlesex County, NJ $40.00-$45.00 1 week ago

Senior Scientist, Analytical Development

Somerset, NJ $165,000.00-$170,000.00 1 week ago

Senior Scientist, Analytical R&D (Inhalation)

Principal Scientist, Molecular Biology Analytics - Analytical Development

New Jersey, United States $30.00-$50.00 1 week ago

Analytical Research and Development Scientist 503B

Senior Scientist, Analytical Taste & Scent

Analytical Scientist I (Princeton, NJ - ON SITE)

New Jersey, United States $50.00-$60.00 8 hours ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.