Scientist II (HPLC Method Validation)

Pace® Analytical Services•Lebanon, NJ

1d•Onsite

About The Position

Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives. This is an onsite full-time Raw Materials Scientist II position located in Lebanon, NJ The primary focus of this position will be performing HPLC method validations in a GMP environment. Monday - Friday, from 8:30 a.m. to 5:00 p.m. Scientist II is responsible for performing routine and non‑routine analytical chemistry testing of raw materials and finished products using USP, EP, JP, and client methods.

Requirements

Bachelor’s or master’s degree required in Chemistry or a related field.
Proficient in HPLC/UPLC, GC, spectroscopy (UV–Vis, FT‑IR), and wet chemistry techniques.
Liquid chromatography method validation experience is required.
Minimum of 5–7 years of pharmaceutical experience, or an equivalent combination of education and experience.
Experience in a cGMP or GLP pharmaceutical environment is required.
Excellent verbal and written communication skills, including the ability to effectively present information and respond to questions from groups of managers, clients, and customers.
Ability to meet deadlines and work under pressure with limited supervision.
Strong time‑management and organizational skills, with the ability to multi‑task and manage multiple projects independently.
Ability to read, analyze, and interpret technical procedures and governmental regulations.
Ability to write reports, business correspondence, and procedure manuals.
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
Ability to apply mathematical operations to tasks such as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret a wide variety of technical instructions in mathematical or diagram form and work with both abstract and concrete variables.
Proficient in computer software, including Microsoft Office Suite and instrument‑manufacturer–based systems.
Knowledgeable in FDA GMPs (21 CFR 211, 820, and/or 600)

Nice To Haves

ISO 9001 and ISO 13485 experience is a plus.

Responsibilities

Perform complex HPLC, UPLC, GC, and other analytical testing, and troubleshoot issues as needed.
Participate in, or assist with, test method validations.
Perform analytical testing of raw materials, finished products, and stability samples using equipment such as balances, pipettes, pH meters, UV/Visible spectrophotometers, Total Organic Carbon analyzers, viscometers, polarimeters, IR instruments, pycnometers, etc.
Conduct onsite sampling of natural gases for customers, including cylinder preparation and leak checks as needed.
Develop, validate, and optimize analytical methods for raw materials and finished products as required.
Serve as backup for QC analytical instrument maintenance and calibration.
Perform general QC laboratory equipment maintenance, maintain laboratory housekeeping, and assist in preparing the laboratory for audits.
Assist QC Management, as needed, with investigations related to OOS results, deviations, and CAPAs.
Ensure analytical results are accurate, reliable, and delivered within required timelines while following proper documentation protocols.