QA R&D Analytical Chemist I - Impactful Pharma Analytics

Tris Pharma, Inc. ( is a leading privately‑owned U.S. biopharmaceutical company focused on developing and commercializing innovative medicines for ADHD, spectrum disorders, anxiety, pain, and addiction. With over 150 U.S. and international patents, the company markets several branded ADHD products in the U.S. and licenses its products globally. Tris also maintains a robust pipeline of neuroscience and other therapeutic products built on proprietary science and technology. Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a QA R&D Analytical Chemist I. The role supports Quality Control and Analytical R&D activities, initiating appropriate change controls and updating specifications. Analytical support includes method improvements, system equivalency, transfers, verifications, alternate source qualifications, and authoring residual‑solvent, elemental‑impurity, and nitrosamine risk assessments. The incumbent may also perform laboratory analyses of raw materials, in‑process testing, finished‑product and stability sample testing, and instrumentation maintenance and calibration. Essential Functions Carries out responsibilities in accordance with company policies, SOPs, and applicable laws. 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 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 in a regulated laboratory environment. Analyzes and interprets test results. Operates general analytical instruments for raw‑material, IP, and FP testing such as HPLC, UPLC, GC, UV/Vis, automatic titration, IR, Malvern Mastersizer, TLC, and dissolution apparatus (Distek). Collaborates closely with R&D for analytical method transfer studies and other related issues. Assists with identification and troubleshooting of instrumentation and analytical preparation problems. 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 safety rules and regulations; adheres to GMPs and GDPs. Performs other QA R&D related tasks assigned by supervisor or management. Requirements Minimum Education and Years of Relevant Experience Bachelor’s degree in Chemistry or related science field and a minimum of 3 years of lab experience in a cGMP‑related industry, or Master’s degree in Chemistry or related science field and a minimum of 1 year of lab experience in a cGMP‑related industry. Special Knowledge or Skills Needed or Licenses or Certificates Required Hands‑on experience with analytical instrumentation (UV, IR, HPLC, UPLC, Malvern Mastersizer, GC, 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. Analytical thinking with problem‑solving skills and adaptability to changing priorities. Planning, organization, and time‑management skills, including capacity to support multiple projects. Fluency in English (spoken and written). Ability to identify and distinguish colors. Willingness to work additional hours as required by business needs. Preferred Knowledge or Skills, Licenses, or Certificates Experience with FDA, ICH guidelines, cGMPs, SOPs, regulatory rules, and guidelines. Proficiency with Empower software and other laboratory software. Experience with wet chemistry and sampling methods, quality‑control systems, analysis, and documentation practices. Prior experience working in a QC lab. Travel Requirements 0% Physical Requirements Laboratory‑based position. Ability to use PPE and stand for extended periods of time. Anticipated salary range $85 k – 95 k. Base salary depends on education, experience, and internal equity. Additional benefits Full‑time employees are eligible for bonus eligibility, medical, dental, vision, Rx insurance, 401(k) with match, life insurance, paid company holidays, PTO, paid volunteer time, and Employee Resource Groups. Tris Pharma, Inc. offers a competitive compensation and benefits package. We encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #J-18808-Ljbffr