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 U.S. and International patents and market several branded ADHD products in the U.S. We also license our products in the U.S. and ex‑U.S. 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 important 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.

Our AR&D lab is located in our Monmouth Junction, NJ headquarters and has an immediate need for an experienced Analytical Research and Development Scientist I.

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, he/she develops advanced analytical knowledge and expertise while carrying out laboratory work to support product development, 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 (HPLC, GC, UV/Vis, 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 disposes 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:

• Bachelor’s 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 Master’s 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 including HPLC, UV/Vis, GC, TLC and dissolution apparatus.
• Understanding and/or ability to work under cGMP, FDA, DEA and OSHA regulations and guidances.
• Ability to perform analytical testing and calculations, as instructed.
• Ability to perform wet chemistry and physical tests, as instructed.
• Proficiency with Microsoft Office.
• Verbal and written communication skills.
• Ability to work independently and collaboratively in a fast‑paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinking with…