AR&D Scientist I/II

Tris Pharma • Monmouth Junction, NJ

13d • Onsite

About The Position

Tris Pharma, Inc. is a biopharmaceutical company focused on developing and commercializing innovative medicines. 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.

Requirements

• 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 industry 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.
• 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
• 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
• Ability to lift up to 30 lbs
• Ability to use Personal Protective Equipment (PPE)
• Ability to stand for extended periods of time

Nice To Haves

• ICP-MS
• LC-MS

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 ARD lab areas
• Performs related duties as assigned
• 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

Benefits

• bonus eligible
• medical
• dental
• vision
• Rx insurance
• 401K with match
• life insurance
• paid Company Holidays
• PTO
• Paid Volunteer Time
• Employee Resource Groups

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level