AR&D Sr. Scientist

Overview

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.

The Analytical Research and Development (AR&D) Senior Scientist I, under minimal guidance, performs analytical method development and troubleshooting of existing methods, designs and executes physical characterization studies to facilitate product understanding. Serving as analytical lead for assigned projects the incumbent provides analytical input to support complex technical investigations, guides highly specialized analytical tasks and conducts research on assigned problems and studies to support product development.

She/he also prepares technical reports and other relevant scientific packages for internal and external use.

• Carries out responsibilities in accordance with company policies, Standard Operating Procedures (SOPs) and state, federal and local laws
• Acts as AR&D lead for assigned development projects liaising with Product Development (PD) department on analytical deliverables
• Sets up and operates analytical instruments to support sample testing, including High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultra Violet Visible spectroscopy (UV/Vis), Infrared Spectroscopy (IR), Thin Layer Chromatography (TLC), automatic titration, Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Liquid Chromatography–Mass Spectroscopy (LC-MS) and dissolution apparatus
• Performs analytical method development and troubleshooting of existing analytical methods for in process (IP), finished products (FP) and stability (ST) sample testing;
  Performs and guides laboratory analyses of raw materials, IP, FP and ST samples
• Designs and executes physical characterization studies to facilitate product understanding, such as rheological, microscopy, surface area and thermal studies
• Designs, guides and performs reverse engineering studies of Reference Listed Drug (RLD) to support Product development
• Designs, guides and performs pre-formulation studies (i.e., pH solubility, pH stability, excipients compatibility studies, etc.) in collaboration with PD
• Performs trend analysis of development stability results, investigates Out of Specification (OOS) and Out of Trend (OOT) results in support of project directives
• Provides analytical input to support complex technical investigations
• Documents all testing details and results in laboratory notebooks compliant with current Good Documentation Practices (cGDPs);
  Prepares analytical method development reports, technical protocols/reports and scientific packages for internal and external use
• Creates and reviews ARD SOPs, as needed
• Safely and properly disposed 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 AR&D lab areas
• Assists and trains lower level scientists
• Performs related duties as assigned

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Minimum Education And Years Of Relevant Work Experience

Bachelors degree in Chemistry or related science field and minimum 10 years experience in analytical development in the pharmaceutical or biotechnology industry OR

Masters degree in Chemistry or related science field and minimum 8 years experience in analytical development in the pharmaceutical or biotechnology industry

OR PhD in Chemistry or related science field and minimum 3 years experience in analytical development in the pharmaceutical or biotechnology industry.

Special knowledge or skills needed and/or licenses or certificates required

• Strong knowledge and experience of physical characterization, thermal, spectroscopic and…