QA R&D Chemist I

Tris Pharma Inc•South Brunswick, NJ

13h•Onsite

About The Position

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. Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a QA R&D Analytical Chemist, I SUMMARY: The Quality Assurance (QA) Research and Development (R&D) Chemist I supports Quality Control (QC) and Analytical R&D (AR&D) activities by initiating appropriate change controls and updating specifications to reflect changes in methods. Analytical support activities include, but are not limited to: method improvements, system equivalency, transfers, verifications, alternate source qualifications and authoring residual solvent, elemental impurity and nitrosamine risk assessments, as directed by R&D. The incumbent may also perform additional responsibilities including laboratory analyses of raw materials, in-process (IP) testing, finished products (FP), stability (ST) sample testing and analytical instrumentation maintenance and calibration.

Requirements

Bachelors degree in Chemistry or related science field and minimum 3 years lab experience in a cGMP related industry OR Masters degree in Chemistry or related science field and minimum 1 years lab experience in a cGMP related industry.
Hands on experience with analytical instrumentation (i.e., UV, IR, HPLC, UPLC, Malvern Mastersizer, GC and/or dissolution instruments) in a pharmaceutical, biotechnology or academic setting
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
Ability and willingness to work additional hours as required by business needs

Nice To Haves

Experience working with Food and Drug Administration (FDA), International Council on Harmonisation (ICH) guidelines, cGMPs and SOPs regulatory rules, regulations and guidelines
Proficiency with Empower software and other laboratory software
Experience with wet chemistry and chemistry related to sampling methods, quality control systems, analysis and documentation practices and procedures
Prior experience working in a QC lab

Responsibilities

Carries out responsibilities in accordance with company policies, Standard Operating Procedures (SOPs) and state, federal and local laws
Creates, reviews or revises SOPs, methods, specifications, verification protocols, reports and change control requests, as needed; Performs vendor qualification for raw materials and packaging materials
Performs testing of raw materials, packaging components, IP, FP and/or ST samples including dissolution, assay, related compounds analysis, content/blend uniformity, particle size distribution by Malvern/Sieve, bulk and Tap density, cleaning validation and other tests according to the analytical methods, United States Pharmacopeia (USP) procedures in a regulated laboratory environment
Analyzes and interprets test results
Operates general analytical instruments during raw material, IP and FP testing such as High Pressure Liquid Chromatography (HPLC), UltraPerformance Liquid Chromatography (UPLC), Gas Chromatography (GC), Ultra Violet visible spectroscopy (UV/Vis), automatic titration, Infra-Red Spectroscopy (IR), Malvern Mastersizer, Thin Layer Chromatography (TLC) and dissolution apparatus (Distek)
Collaborates closely with R&D for analytical method transfer studies and other analytical method related issues
Assists with the identification and troubleshooting of problems with instrumentation and analytical preparations
Authors Residual Solvent, Elemental Impurity and Nitrosamine risk assessments
Meets project deadlines and performance standards, as assigned
Maintains a clean and organized lab area
Complies with all Company policies and procedures, including safety rules and regulations
Adheres to GMPs and GDPs
Any other QA R&D related tasks assigned by Supervisor or QA R&D Management