AR&D Scientist

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 I, under supervision, performs laboratory analyses of raw materials, in process (IP), finished products (FP) and stability (ST) samples. The incumbent also performs required maintenance and calibration of analytical instruments. Collaborating closely with, and under the direct supervision of, Senior ARD Scientists and Supervisors, she/he develops advanced analytical knowledge and expertise while carrying out laboratory work to support product development and analytical method development and performs special projects, as assigned.

• Carries out responsibilities in accordance with company policies, SOPs and state, federal and local laws
• Sets up and operates analytical instruments (i.e., High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultra Violet Visible spectroscopy (UV/Vis), Thin Layer Chromatography (TLC), automatic titration, dissolution apparatus, etc.) to support sample testing
• Performs laboratory analyses, such as blend uniformity, content uniformity, assay and dissolution, of IP, FP and ST samples per given instructions;
  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 such as particle size, viscosity and density measurements
• Performs all necessary calculations associated with test analyses
• Documents all testing details and results in laboratory notebooks compliant with current Good Documentation Practices (cGDPs)
• Creates ARD SOPs, as needed
• Safely and properly dispose of chemical waste, as needed
• Cleans, maintains and calibrates laboratory instruments to ensure compliance with current Good Laboratory Practices (cGLPs) and current Good Manufacturing Practices (cGMPs)
• Cleans and organizes ARD lab areas
• Performs related duties, as assigned

Minimum education and years of relevant work experience

Bachelors degree in Chemistry or related science field and minimum 3 years experience in analytical/method development or method validation in the pharmaceutical or biotechnology industry OR Masters degree in Chemistry or related science field and minimum 0-3 years experience in analytical/method development or method validation in the pharmaceutical or biotechnology industry.

• 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 and dissolution apparatus
• Understanding and/or ability to work under cGMP, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA) and Occupational Safety and Health Administration (OSHA) regulations and guidances
• Ability to perform analytical testing and calculations, as instructed
• Ability…