Method Validation Scientist II

• Location: Middlesex County, NJ
• Type: Direct Hire
• Job #38151
• Salary: $105,000.00

Title:    MV Scientist II
Team / Department:     Method Validation, R&D / Analytical Development, R&D    

Summary:
Under supervision, performs laboratory analyses of raw materials, in process (IP), finished products (FP) and stability (ST) samples for pilot and submission batches, according to SOPs and cGMP procedures. Prepares method validation protocols/reports, and carries out method validation activities, including interim method validation, to meet project timelines. Supports laboratory investigations and performance of non-routine testing such as method comparisons and evaluations. Tracks and maintains sample flow. Required to adhere strictly to company policies and current industry standards.

Essential Job Functions: 

• Carries out responsibilities in compliance with all cGMP, FDA, DEA, and OSHA regulations, as well as all applicable company compliance guidelines, policies, standards and objectives.
• Sets up and operates analytical instruments including (but not limited to) HPLC, GC, UV/Vis, Automatic titration, IR, AA, TLC and dissolution apparatus to support sample testing.
• Performs laboratory analyses of raw materials, in process (IP), finished products (FP) and stability (ST) samples. Prepares standard and sample solutions as required by the test methods.
• Performs wet chemistry tests such as LOD, pH, and titration.
• Performs physical tests including thermal analysis, particle size, viscosity, and density measurements.
• Performs all necessary calculations associated with test analyses.
• Labels, transcribes and records all testing details and results in laboratory notebooks and report sheets, compliant with GDP, cGMP and SOPs. 
• Cleans, maintains and calibrates laboratory instruments to ensure compliance with cGLP and cGMP.
• Creates MV SOPs as needed.
• Prepares method validation/verification protocols and reports.
• Performs qualitative and quantitative analysis to support reference standard qualifications, method validation, method comparisons and transfers. 
• Performs investigations, evaluates and verifies compendial methods.
• Tracks and maintains sample flow.
• Cleans and organizes MV lab areas.
• Performs related duties as assigned.

Required Knowledge, Skills and Experience:

• Understanding of spectroscopic and chromatographic techniques and concepts.
• Hands-on experience in setting up and operating UV/IR, HPLC, GC, TLC and dissolution apparatus
• Working knowledge of FDA and cGMPs regulations and guidances as well as DEA and OSHA requirements.
• Knowledge of method validation parameters and their relevance in method performance.
• Strong understanding of QA/QC systems, including change control systems.
• Ability to perform analytical testing, calculations and data analysis as instructed.
• Ability to perform wet chemistry and physical testings as instructed.
• Ability to work collaboratively, as required, in a fast-paced environment.
• Ability to abide by company policies, practices and procedures, including cGMP, GDP and SOP requirements
• Good verbal and written communication skills.
• Ability to operate computer systems and software applications, including Microsoft office.

Required Behavior:

• Action-oriented and motivated, with a sense of urgency and enthusiasm.
• Focus on performance, quality and excellence.
• Willing to finding new and better ways to be successful.
• Adaptive to changes.
• Learning driven.
• Hold self accountable to meet commitments.
• Collaborative, team player.
• Transparent and authentic.
• Adheres to high ethical principles, integrity and professional standards.

Minimum Qualifications:  Bachelor’s Degree in Chemistry or related scientific field, with at least five (5+) years, or Master’s Degree in Chemistry or related scientific field, with at least three (3+) years of experience in analytical development, method validation or quality control in the pharmaceutical field