QA R&D Chemist I

Tris Pharma Inc•South Brunswick, NJ

73d•$85,000 - $95,000•Onsite

About The Position

Tris Pharma, Inc. is a privately-owned U.S. biopharmaceutical company focused on developing and commercializing innovative medicines for ADHD, spectrum disorders, anxiety, pain, and addiction. The company holds over 150 US and International patents and markets several branded ADHD products in the U.S., while also licensing products domestically and internationally. Tris has a strong pipeline of innovative products in neuroscience and other therapeutic areas, utilizing its proprietary science and technology. The company values its team members, recognizing them as the driving force behind its passion and innovation. Colleagues understand the importance of operating a successful business and take pride in the company's achievements. Tris emphasizes respectful, open, and honest communication to support individual and team success. This role is located in Monmouth Junction, New Jersey.

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 skills.
Ability to work independently and collaboratively in a fast-paced, matrixed, team environment.
Analytical thinking with problem-solving skills.
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

Supports Quality Control (QC) and Analytical R&D (AR&D) activities by initiating appropriate change controls and updating specifications to reflect changes in methods.
Performs analytical support activities including method improvements, system equivalency, transfers, verifications, alternate source qualifications, and authoring residual solvent, elemental impurity, and nitrosamine risk assessments.
Performs laboratory analyses of raw materials, in-process (IP) testing, finished products (FP), stability (ST) sample testing, and analytical instrumentation maintenance and calibration.
Creates, reviews, or revises SOPs, methods, specifications, verification protocols, reports, and change control requests.
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 analytical methods and United States Pharmacopeia (USP) procedures in a regulated laboratory environment.
Analyzes and interprets test results.
Operates general analytical instruments 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 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.
Maintains a clean and organized lab area.
Complies with all Company policies and procedures, including safety rules and regulations.
Adheres to GMPs and GDPs.
Performs any other QA R&D related tasks assigned by Supervisor or QA R&D Management.