AR&D Scientist I/II

About the role

Tris Pharma, Inc. is a leading privately-owned U.S. biopharmaceutical company focused on developing and commercializing innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction to address unmet patient needs. The company holds over 150 U.S. and international patents and markets several branded ADHD products in the U.S., while licensing products domestically and internationally. Tris maintains a robust pipeline of innovative products across neuroscience and other therapeutic areas, leveraging proprietary science and technology. The Analytical Research and Development (ARD) lab at the Monmouth Junction, NJ headquarters has an immediate need for experienced Analytical Research and Development Scientists at various levels.

Responsibilities

• Perform laboratory analyses of raw materials, in-process (IP), finished products (FP), and stability (ST) samples under supervision.
• Set up and operate analytical instruments including High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC), UV/Vis spectroscopy, IR spectroscopy, TLC, automatic titration, ICP-MS, LC-MS, and dissolution apparatus.
• Develop and troubleshoot analytical methods for IP, FP, and ST sample testing.
• Design and execute physical characterization studies (e.g., rheology, microscopy, surface area, thermal analysis).
• Conduct reverse engineering studies of Reference Listed Drugs (RLD) to support product development.
• Perform pre-formulation studies such as pH solubility, pH stability, and excipient compatibility studies in collaboration with PD teams.
• Conduct trend analysis of development stability results and investigate Out of Specification (OOS) and Out of Trend (OOT) results.
• Provide analytical input to support complex technical investigations.
• Document testing details and results in laboratory notebooks compliant with current Good Documentation Practices (cGDPs).
• Prepare analytical method development reports, technical protocols/reports, and scientific packages for internal and external use.
• Create and review ARD SOPs as needed.
• Safely dispose of chemical waste and maintain clean, organized laboratory areas.
• Clean, maintain, and calibrate laboratory instruments to ensure compliance with cGLPs and cGMPs.

Requirements

• ARD Scientist I:
  • Bachelor’s degree in Chemistry or related science field and minimum 3 years of 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 0–3 years of relevant experience.
• ARD Scientist II:
  • Bachelor’s degree in Chemistry or related science field and minimum 4 years of 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 2 years of relevant experience.
  • OR PhD in Chemistry or related science field with 0–1 years of experience in analytical/method development or method validation in the pharmaceutical, biotechnology, or academic research field.
• Ability to operate analytical instruments such as HPLC, GC, UV/Vis, TLC, automatic titration, dissolution apparatus, and perform wet chemistry tests (e.g., LOD, pH, titration) and physical tests (e.g., particle size, viscosity, density).
• Experience documenting results in compliance with cGDPs and maintaining laboratory compliance with cGLPs and cGMPs.
• Ability to lift up to 30 lbs, use PPE, stand for extended periods, and safely handle chemical waste.

Benefits

• Bonus eligible position.
• Medical, dental, vision, and Rx insurance.
• 401(k) with employer match.
• Life insurance.
• Paid company holidays and PTO.
• Paid volunteer time.
• Access to Employee Resource Groups.