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 Scientist III.

Summary

The Analytical Research and Development (ARD) Scientist III, under guidance, performs laboratory analyses of raw materials, in process (IP), finished product (FP) and stability (ST) samples, as well as maintenance and calibration of analytical instruments. The incumbent also executes physical characterization studies to facilitate product understanding and performs technical and specialized analytical tasks, conducts research on assigned problems and studies to support product development, method development and technical investigations. She/he supports laboratory investigations and performance of non-routine testing such as method comparisons and evaluations. The incumbent also assists and trains lower-level scientists.

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 (i.e., High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet Visible spectroscopy (UV/Vis), Infra-Red Spectroscopy (IR), Thin Layer Chromatography (TLC), automatic titration, Inductively Coupled Plasma Mass spectrometry (ICP-MS), dissolution apparatus, etc.) to support sample testing

· Performs all laboratory analyses of raw materials, IP, FP and ST samples; 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 and studies (i.e., particle size, viscosity, density, rheological measurements, microscopies and thermal analysis)

· Performs all necessary calculations associated with test analyses

· Designs and executes pre-formulation studies (i.e., pH solubility, pH stability and excipients compatibility studies) in collaboration with Product Development (PD) department

· Executes designed studies to support laboratory investigations

· Performs non-routine testing such as method comparisons and evaluations

· Documents all testing details and results in laboratory notebooks compliant with current Good Documentation Practices (cGDPs)

· Assists and trains lower-level scientists

· Creates and reviews ARD SOPs as needed

· Cleans, maintains and calibrates laboratory instruments to ensure compliance with current Good Laboratory Practices (cGLPs) and Good Manufacturing Practices (cGMPs)

· Cleans and organizes ARD lab areas

· Performs related duties, as assigned

Requirements

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Minimum education and years of relevant work experience

Bachelor’s degree in Chemistry or related science field and minimum 8 years’ 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 5 years’ experience in analytical/method development or method validation in the pharmaceutical or biotechnology field OR PhD in Chemistry or related science field with 1-3 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

· Understanding of spectroscopic and chromatographic techniques and concepts

· Hands on experience in setting up and operating multiple analytical instrumentation which may include: HPLC, UV/Vis, GC, TLC, ICP-MS and dissolution apparatus

· Working knowledge of FDA and cGMPs regulations and guidances as well as DEA and OSHA requirements

· Ability to perform analytical testing, calculations and data analysis

· Ability to perform wet chemistry and physical characterization studies

· Ability to train and mentor lower levels scientist

· Proficiency with Microsoft Office

· Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members

· Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines

· Planning, organization and time management skills including the ability to support and prioritize multiple projects

· Fluent in English (verbal and written)

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

· Proficiency with Empower software

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: $95k to $115k. 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.