Tris Pharma
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QC Analytical Chemist
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Tris Pharma Tris Pharma, Inc. (www.trispharma.com) 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, the company markets several branded ADHD products in the United States and licenses its products in U.S. and ex‑U.S. markets. A robust pipeline spans neuroscience and other therapeutic categories, employing proprietary science and technology. Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Quality Control (QC) Analytical Chemist. The QC Analytical Chemist performs analytical testing of raw materials, packaging components, in‑process (IP), finished product (FP), stability samples (ST) and method verifications following United States Pharmacopeia (USP)/National Formulary Chapters, protocols, Standard Operating Procedures (SOPs) under current Good Manufacturing Practices (cGMPs) and company policies. Collaborating closely under the direct supervision of Senior QC Analytical Chemists, Team Leads and QC Managers, the incumbent develops advanced analytical knowledge while carrying out laboratory work to support QC activities and performs special projects as assigned. Responsibilities
Carries out responsibilities in accordance with company policies, SOPs, and state, federal, and local laws. Performs testing of raw materials, 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 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), Atomic Absorption (AA), Malvern Particle Size Analyzer, Thin Layer Chromatography (TLC) and dissolution apparatus (Distek). Displays proficiency in creating and using custom fields in Empower software while operating HPLC/UPLC and GC instruments. Assists with the identification and troubleshooting of problems with instrumentation and analytical preparations. Meets project deadlines and performance standards as assigned. Complies with all company policies and procedures, including safety rules and regulations. Adheres to cGMPs and current Good Documentation Practices (cGDPs). Requirements
Minimum education and years of relevant work experience: Chemist I – Bachelor’s degree in Chemistry or related science field and 1–5 years of 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, GC, and/or dissolution instruments) in a pharmaceutical or biotechnology setting. Strong hands‑on experience performing and interpreting related compounds (impurity) analysis. Demonstrated ability to apply good laboratory techniques while maintaining efficiencies required in a QC lab. 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). Willingness to work additional hours as required by business needs. Ability to identify and distinguish colors. Special knowledge or skills needed and/or licenses or certificates preferred: Experience with FDA, current Good Laboratory Practices (cGLPs), cGMPs, SOPs, and regulatory rules, regulations, and guidelines. Proficiency with Empower software. Ability and/or experience training and mentoring lower‑level chemists. Experience with wet chemistry and chemistry related to sampling methods, quality control systems, analysis, and documentation practices and procedures. Travel requirements
0% travel. Physical requirements
Laboratory‑based position. Ability to lift up to 30 lbs. Ability to use Personal Protective Equipment (PPE). Ability to stand for extended periods of time. Anticipated salary range: $70k – $80k. Base salary is contingent upon assessment of candidate’s education and experience relative to the position’s requirements and a review of related industry standards and internal equity. Additional benefits: Base salary is complemented by a full‑time program that includes incentive bonuses, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid company holidays, PTO, paid volunteer time, and Employee Resource Groups. Tris Pharma, Inc. encourages applications from individuals with disabilities, minorities, veterans, women, LGBTQ, and other under‑represented groups. Tris Pharma, Inc. is an Equal Opportunity Employer.
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QC Analytical Chemist
role at
Tris Pharma Tris Pharma, Inc. (www.trispharma.com) 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, the company markets several branded ADHD products in the United States and licenses its products in U.S. and ex‑U.S. markets. A robust pipeline spans neuroscience and other therapeutic categories, employing proprietary science and technology. Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Quality Control (QC) Analytical Chemist. The QC Analytical Chemist performs analytical testing of raw materials, packaging components, in‑process (IP), finished product (FP), stability samples (ST) and method verifications following United States Pharmacopeia (USP)/National Formulary Chapters, protocols, Standard Operating Procedures (SOPs) under current Good Manufacturing Practices (cGMPs) and company policies. Collaborating closely under the direct supervision of Senior QC Analytical Chemists, Team Leads and QC Managers, the incumbent develops advanced analytical knowledge while carrying out laboratory work to support QC activities and performs special projects as assigned. Responsibilities
Carries out responsibilities in accordance with company policies, SOPs, and state, federal, and local laws. Performs testing of raw materials, 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 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), Atomic Absorption (AA), Malvern Particle Size Analyzer, Thin Layer Chromatography (TLC) and dissolution apparatus (Distek). Displays proficiency in creating and using custom fields in Empower software while operating HPLC/UPLC and GC instruments. Assists with the identification and troubleshooting of problems with instrumentation and analytical preparations. Meets project deadlines and performance standards as assigned. Complies with all company policies and procedures, including safety rules and regulations. Adheres to cGMPs and current Good Documentation Practices (cGDPs). Requirements
Minimum education and years of relevant work experience: Chemist I – Bachelor’s degree in Chemistry or related science field and 1–5 years of 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, GC, and/or dissolution instruments) in a pharmaceutical or biotechnology setting. Strong hands‑on experience performing and interpreting related compounds (impurity) analysis. Demonstrated ability to apply good laboratory techniques while maintaining efficiencies required in a QC lab. 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). Willingness to work additional hours as required by business needs. Ability to identify and distinguish colors. Special knowledge or skills needed and/or licenses or certificates preferred: Experience with FDA, current Good Laboratory Practices (cGLPs), cGMPs, SOPs, and regulatory rules, regulations, and guidelines. Proficiency with Empower software. Ability and/or experience training and mentoring lower‑level chemists. Experience with wet chemistry and chemistry related to sampling methods, quality control systems, analysis, and documentation practices and procedures. Travel requirements
0% travel. Physical requirements
Laboratory‑based position. Ability to lift up to 30 lbs. Ability to use Personal Protective Equipment (PPE). Ability to stand for extended periods of time. Anticipated salary range: $70k – $80k. Base salary is contingent upon assessment of candidate’s education and experience relative to the position’s requirements and a review of related industry standards and internal equity. Additional benefits: Base salary is complemented by a full‑time program that includes incentive bonuses, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid company holidays, PTO, paid volunteer time, and Employee Resource Groups. Tris Pharma, Inc. encourages applications from individuals with disabilities, minorities, veterans, women, LGBTQ, and other under‑represented groups. Tris Pharma, Inc. is an Equal Opportunity Employer.
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