Scientist II (HPLC Method Validation)

Shift:

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 nonroutine analytical chemistry testing of raw materials and finished products using USP, EP, JP, and client methods.

Essential Functions

• 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.

Qualifications

Education and Experience

• Bachelor's or master's degree required in Chemistry or a related field.
• Proficient in HPLC/UPLC, GC, spectroscopy (UV-Vis, FTIR), 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.

Required Knowledge and Skills

• 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 timemanagement and organizational skills, with the ability to multitask 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 instrumentmanufacturer-based systems.
• Knowledgeable in FDA GMPs (21 CFR 211, 820, and/or 600); ISO 9001 and ISO 13485 experience is a plus.

Physical/Mental Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform these functions.

• Mobility to work in both lab and office settings, and to use standard office and laboratory equipment.
• Stamina to sit for extended periods.
• Ability to exert up to 50 pounds of force occasionally and/or up to 40 pounds frequently to lift, carry, push, pull, or move objects.
• Sufficient vision to read printed materials and computer screens.
• Adequate hearing and speech to communicate in person or by telephone.

Working Environment

• Work is performed in both laboratory and office environments.
• Exposure to chemicals, fumes, gases, noxious odors, and related substances commonly found in laboratory settings should be expected.

Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work.

Benefits
When you join Pace, you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft.

Equal Opportunity Employer

Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.