QA R&D Chemist I

Tris Pharma, Inc. ( is a leading privately‑owned U.S. biopharmaceutical company focused on the development and commercialization of innovative medicines for ADHD, spectrum disorders, anxiety, pain, and addiction. With over 150 U.S. and international patents, we market several branded ADHD products in the U.S. and license our products in U.S. and ex‑U.S. markets. We have a robust pipeline spanning neuroscience and other therapeutic categories using proprietary science and technology.

SUMMARY

The Quality Assurance (QA) Research and Development (R&D) Chemist I supports Quality Control (QC) and Analytical R&D activities by initiating appropriate change controls and updating specifications to reflect changes in methods. Analytical support activities include 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 laboratory analyses of raw materials, in‑process (IP) testing, finished products (FP), stability (ST) sample testing, and analytical instrumentation maintenance and calibration.

ESSENTIAL FUNCTIONS

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 analytical methods and 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. Performs any other QA R&D related tasks assigned by supervisor or QA R&D management.

QUALIFICATIONS

Minimum Education And Years Of Relevant Work Experience Bachelor’s degree in Chemistry or a related scientific field and a minimum of 3 years laboratory experience in a cGMP related industry, or Master’s degree in Chemistry or a related scientific field and a minimum of 1 year laboratory experience in a cGMP related industry. Special Knowledge or Skills Needed and/or Licenses or Certificates Required Hands‑on experience with analytical instrumentation (UV, IR, HPLC, UPLC, Malvern Mastersizer, GC, and/or dissolution instruments) in a pharmaceutical, biotechnology or academic setting. Proficiency with Microsoft Office. Strong verbal and written communication skills. Ability to work independently and collaboratively 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. Availability and willingness to work additional hours as required by business needs. Special Knowledge or Skills Needed and/or Licenses or Certificates Preferred Experience 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.

TRAVEL REQUIREMENTS

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PHYSICAL REQUIREMENTS

Laboratory based position. Ability to use Personal Protective Equipment (PPE). Ability to stand for extended periods of time.

ANTICIPATED SALARY RANGE

$85,000 – $95,000. 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 eligible for bonus eligibility, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid company holidays, paid time off, 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. #J-18808-Ljbffr Tris Pharma