Scientist II or III Analytical Chemist (Drug Product) - FSP

Parexel International; Rahway (NJ); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Full benefits

Sick time

401K

Paid holidays

Paid time off

Job summary

Parexel FSP is seeking a Scientist 2 or 3—Analytical Chemist (Drug Product) for a full-time, onsite role at our client site in Rahway, NJ. You will perform routine and stability sample analyses, SOP authoring, and troubleshooting within a compliance-focused lab environment.

The ideal candidate has a BS/MS in Chemistry or related field and hands-on GMP experience with HPLC/UPLC, data integrity, and method development.

Qualifications

• B.S./M.S. in Chemistry, Biochemistry, Engineering, or a related discipline.
• Experience with GMP analysis using HPLC/UPLC including assay/impurity/etc., troubleshooting and data processing interpretation / analysis
• Routine testing, data integrity assessments, investigative report authoring, and/or sample management responsibilities
• Strong computer, scientific, and organizational skills
• Clear communicator who speaks up about problems and improvement ideas
• Able to manage multiple ongoing projects
• Ability to work independently and as part of a team
• Self-motivation, efficiency, adaptability, and a positive attitude

Responsibilities

• In the drug product registration stability testing lab, you'll perform routine and stability sample analysis, SOP authoring, and day-to-day problem solving while contributing to new technologies and continuous improvement measures for optimized lab operations and other testing requirements.
• You'll apply analytical characterization technologies and compliance principles to drive method robustness and high-quality stability data supporting late-stage pharmaceutical drug product development and commercialization.
• The ideal candidate is proactive, collaborative, and thrives in a compliance-focused environment.

Skills

GMP with HPLC/UPLC

Data processing interpretation

Independent and team work

Clear communication

Project management

Self-motivation

Education

BS/MS in Chemistry/Biochemistry/Engineering

Tools

Empower software

Job description

We are looking to fill a Scientist 2 or 3 - Analytical Chemist (Drug Product) position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in Rahway, NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer any sponsorship.

Qualifications-

B.S./M.S. in Chemistry, Biochemistry, Engineering, or a related discipline

• Scientist 2 - B.S. with 1-2 years of relevant experience

• Scientist 3 - B.S. with 3-5 years of relevant experience or M.S. with 1-2 years of relevant experience

Required Skills and Experience

• Experience with GMP analysis using HPLC/UPLC including assay/impurity/etc., troubleshooting and data processing interpretation / analysis

• Routine testing, data integrity assessments, investigative report authoring, and/or sample management responsibilities

• Strong computer, scientific, and organizational skills

• Clear communicator who speaks up about problems and improvement ideas

• Able to manage multiple ongoing projects

• Ability to work independently and as part of a team

• Self-motivation, efficiency, adaptability, and a positive attitude

Desired Skills and Experience

• Experience with Dissolution, Karl Fischer (KF), moisture testing and other wet chemistry skills

• Empower software

• Analysis of drug products

• Good understanding of cGMP compliance requirements and ALCOA documentation principle

Overview

In the drug product registration stability testing lab, you'll perform routine and stability sample analysis, SOP authoring, and day-to-day problem solving while contributing to new technologies and continuous improvement measures for optimized lab operations and other testing requirements. You'll apply analytical characterization technologies and compliance principles to drive method robustness and high-quality stability data supporting late-stage pharmaceutical drug product development and commercialization. The ideal candidate is proactive, collaborative, and thrives in a compliance-focused environment.

About Parexel

Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement.

Come join us!

#LI-DK1

EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.