AR&D Scientist III - TEMP

Description

Tris Pharma, Inc. () is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success.

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.

• 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, micros copies and thermal analysis)
• Preforms 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

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…