AR&D Scientist I

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 companys 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 I

Summary

The Analytical Research and Development (ARD) Scientist I, 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, 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

Requirements

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Minimum education and years of relevant work experience

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.

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 and dissolution apparatus

Understanding and/or ability to work under cGMP, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA) and Occupational Safety and Health Administration (OSHA) regulations and guidances

Ability to perform analytical testing and calculations, as instructed

Ability to perform wet chemistry and physical testings, as instructed

Proficiency with Microsoft Office

Verbal and written communication and skills

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)

Ability to identify and distinguish colors

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: $63k to $85k. Base salary offered is contingent on assessment of candidates 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-_