AR&D Sr. Scientist II

Description

Tris Pharma, Inc. (www.trispharma.com) 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.

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

Summary

The Analytical Research and Development (ARD) Senior Scientist II, under minimal guidance, designs and guides pre-formulation and complex physical characterization studies to facilitate understanding of material attributes and product performance. The incumbent also performs and leads pre-formulation, physical characterization and non-routine analytical method development. 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.    

ESSENTIAL FUNCTIONS 

Primary duties/responsibilities

• Carries out responsibilities in accordance with company policies, Standard Operating procedures (SOPs), and state, federal and local laws
• Designs and guides complex physical characterization studies to facilitate understanding of material attributes and product performance, such as spectroscopic, rheologic, microscoic, surface area, polymorphic and thermal studies; research and implement novel techniques and instruments 
• Designs, guides and performs pre-formulation studies (such as pH solubility, pH stability, excipients compatibility studies, etc.) in collaboration with Product Development (PD) department
• Designs, guides and performs non-routine and specialized method development of complex analysis, such as biorelevant dissolution method, unknown impurity identification, etc.  
• Designs, guides and performs reverse engineering studies of complex reference products to support product development
• Acts as analytical R&D lead for assigned development projects and liaises with PD department on analytical deliverables
• Sets up and operates analytical instruments to support sample testing, including High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultra Violet Visible spectroscopy (UV/Vis), automatic titration, Infrared Spectroscopy (IR), Thin Layer Chromatography (TLC), Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Liquid Chromatography–Mass Spectroscopy (LC-MS and LC-MS/MS), Gas Chromatography-Mass Spectroscopy (GC-MS) and dissolution apparatus
• Performs and leads analytical method development and troubleshooting of complex analytical methods in compliance with ICH/FDA guidances for raw materials, in process (IP), finished products (FP) and stability (ST) sample testing, as needed  
• Performs data and trend analysis for study results 
• Investigates Out of Specification (OOS) and Out of Trend (OOT) results in support of project directives, as needed 
• Provides analytical input to support highly 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
• Troubleshoots and solves problems during routine testing, including instruments malfunction and analyst errors
• Assists and trains lower-level scientists
• Continuously improves and streamlines ARD capabilities, processes and systems, including identification and implementation of instrumentation and software
• Reviews ARD SOPs, as needed
• Safely and properly disposed of chemical waste, as needed
• Cleans, maintains and calibrates laboratory instruments to ensure compliance with