AR&D Scientist III - TEMP

Tris Pharma•Monmouth Junction, NJ

30d•Onsite

About The Position

The Analytical Research and Development (ARD) Scientist III, under guidance, performs laboratory analyses of raw materials, in process (IP), finished product (FP) and stability (ST) samples, as well as maintenance and calibration of analytical instruments. The incumbent also executes physical characterization studies to facilitate product understanding and performs technical and specialized analytical tasks, conducts research on assigned problems and studies to support product development, method development and technical investigations. She/he supports laboratory investigations and performance of non-routine testing such as method comparisons and evaluations. The incumbent also assists and trains lower-level scientists.

Requirements

Minimum education and years of relevant work experience Bachelor’s degree in Chemistry or related science field and minimum 8 years’ experience in analytical/method development or method validation in the pharmaceutical or biotechnology field OR Master’s degree in Chemistry or related science field and minimum 5 years’ experience in analytical/method development or method validation in the pharmaceutical or biotechnology field OR PhD in Chemistry or related science field with 1-3 years’ experience in analytical/method development or method validation in the pharmaceutical, biotechnology and/or academic research field.
Understanding of spectroscopic and chromatographic techniques and concepts
Hands on experience in setting up and operating multiple analytical instrumentation which may include: HPLC, UV/Vis, GC, TLC, ICP-MS and dissolution apparatus
Working knowledge of FDA and cGMPs regulations and guidances as well as DEA and OSHA requirements
Ability to perform analytical testing, calculations and data analysis
Ability to perform wet chemistry and physical characterization studies
Ability to train and mentor lower levels scientist
Proficiency with Microsoft Office
Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
Planning, organization and time management skills including the ability to support and prioritize multiple projects
Fluent in English (verbal and written)
Laboratory based position
Ability to lift up to 30 lbs
Ability to use Personal Protective Equipment (PPE)
Ability to stand for extended periods of time

Nice To Haves

Proficiency with Empower software

Responsibilities

Carries out responsibilities in accordance with company policies, Standard Operating Procedures (SOPs), and state, federal and local laws
Sets up and operates analytical instruments (i.e., High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet Visible spectroscopy (UV/Vis), Infra-Red Spectroscopy (IR), Thin Layer Chromatography (TLC), automatic titration, Inductively Coupled Plasma Mass spectrometry (ICP-MS), dissolution apparatus, etc.) to support sample testing
Performs all laboratory analyses of raw materials, IP, FP and ST samples; Prepares standard and sample solutions as required by the test methods.
Performs wet chemistry tests such as Limit of Detection (LOD), pH and titration
Performs physical tests and studies (i.e., particle size, viscosity, density, rheological measurements, microscopies and thermal analysis)
Performs all necessary calculations associated with test analyses
Designs and executes pre-formulation studies (i.e., pH solubility, pH stability and excipients compatibility studies) in collaboration with Product Development (PD) department
Executes designed studies to support laboratory investigations
Performs non-routine testing such as method comparisons and evaluations
Documents all testing details and results in laboratory notebooks compliant with current Good Documentation Practices (cGDPs)
Assists and trains lower-level scientists
Creates and reviews ARD SOPs as needed
Cleans, maintains and calibrates laboratory instruments to ensure compliance with current Good Laboratory Practices (cGLPs) and Good Manufacturing Practices (cGMPs)
Cleans and organizes ARD lab areas
Performs related duties, as assigned