Analytical R&D Scientist I/II — Method Development & QC

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. Our AR&D lab located in our Monmouth Junction, NJ headquarters, has an immediate need for experienced Analytical Research and Development Scientists, at various levels. Title and salary commensurate with experience. See below.

SUMMARY

The Analytical Research and Development (ARD) Scientist, 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.

ESSENTIAL FUNCTIONS

Primary duties/responsibilities Carries out responsibilities in accordance with company policies, Standard Operating Procedures (SOPs) and state, federal and local laws 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 Performs related duties as assigned Requirements

REQUIRMENTS/QUALIFICATIONS

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Minimum education and years of relevant work experience for AR&D Scientist I 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 Minimum education and years of relevant work experience for AR&D Scientist II Bachelors degree in Chemistry or related science field and minimum 4 years experience in analytical/method development or method validation in the pharmaceutical or biotechnology field OR Masters degree in Chemistry or related science field and minimum 2 years experience in analytical/method development or method validation in the pharmaceutical or biotechnology field OR PhD in Chemistry or related science field with 0-1 years experience in analytical/method development or method validation in the pharmaceutical, biotechnology and/or academic research field. Special knowledge or skills needed and/or licenses or certificates required 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 Travel requirements 0% Physical requirements Laboratory based position Ability to lift up to 30 lbs Ability to use Personal Protective Equipment (PPE) Ability to stand for extended periods of time Anticipated salary range Scientist I: $65k to $85k. Anticipated salary range Scientist II: $80k to $100k Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity. Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups. Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-_ #J-18808-Ljbffr Tris Pharma, Inc.