Job Title: Method Validation Scientist

　　Location: Monmouth Junction, NJ

　　Hours/Schedule: M-F, 8 am - 5 pm

　　Type: Direct Hire

　　Responsibilities

　　Perform method validation studies to support testing of raw materials, in process (IP), finished products (FP) and stability (ST) samples of test batches.

　　Carries out responsibilities in accordance with the organization’s policies, Standard Operating Procedures (SOPs), and state, federal and local laws

　　Operates general analytical instruments during raw material, IP and FP testing such as High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC,), Ultra Violet visible spectroscopy (UV/Vis), automatic titration, Infra Red Spectroscopy (IR), Atomic Absorption ( AA), Thin Layer Chromatography (TLC) and dissolution apparatus

　　Performs wet chemistry tests such as loss on drying (LOD), pH, and titration; Performs physical testing (i.e., viscosity and density measurements, etc.)

　　Labels, transcribes and records documentation such as report sheets and laboratory notebooks as required by SOPs

　　Collaborating closely with the Metrology department, cleans, maintains and calibrates laboratory equipment to ensure compliance with current Good Laboratory Practices (cGLPs) and current Good Manufacturing Practices (cGMP)

　　Assists with the investigations and method validation

　　Carries out quantitative and qualitative analyses during method validation

　　Requirements

　　Minimum of bachelor's degree in Chemistry or related scientific field

　　2-5 years of Pharmaceutical AR&D method validation experience. QC based Method validation experience will not be accepted.

　　Knowledge and experience of spectroscopic and chromatographic techniques and concepts.

　　Hands-on experience in setting up and operating any/all of following equipment: LC-MS, GC, GC-MS, ICP-MS.

　　Hands-on experience in setting up and operating UV/IR, HPLC, TLC and dissolution apparatus.

　　Working knowledge of FDA and cGMPs regulations and guidances as well as DEA and OSHA requirements.

　　Strong knowledge of qualitative and quantitative method validation parameters and their relevance in method performance.

　　Soft skills: not a lot of inter-department communication at this level, mostly bench.

　　Benefits

　　System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

　　System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

　　System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.