AR&D Scientist II

Description

Analytical Research and Development Scientist II

Monmouth Junction, NJ

Department: Analytical Research and Development and Characterization / Analytical Development, R&D

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 Scientist II

Summary

The Analytical Research and Development (ARD) Scientist II, under supervision, performs laboratory analyses of raw materials, in process (IP), finished products (FP) and stability (ST) samples and executes physical characterization studies to facilitate product understanding. The incumbent also performs other lab assignments including, but not limited to: maintenance and calibration of analytical instruments, carries out and documents laboratory work to support product development and analytical method development and supports laboratory investigations and performance of non-routine testing such as method comparisons and evaluations.

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), Ultra Violet Visible spectroscopy (UV/Vis), Infra-Red Spectroscopy (IR), Thin Layer Chromatography (TLC), automatic titration, 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 such as particle size, viscosity and density measurements
• Performs all necessary calculations associated with test analyses
• 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)
• 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 Good Manufacturing Practices (cGMPs)
• Cleans and organizes ARD lab areas
• Performs related duties, as assigned

Requirements

Requirements

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Minimum education and years of relevant work experience

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

• 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
• Working knowledge of 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, calculations and data analysis, 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: $85k to $105k. 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-_