QC Analytical Chemist I

Monmouth Junction, NJ • QC

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and 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 it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other, and we believe 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 

Quality Control (QC) Analytical Chemist I. 

The Quality Control (QC) Analytical Chemist I perform analytical testing of raw materials, packaging components, in-process (IP), finished product (FP), stability samples (ST), analytical method transfers and method verifications following analytical methods, United States Pharmacopeia (USP)/National Formulary Chapters, protocols, Standard Operating Procedures (SOPs) under current Good Manufacturing Practices (cGMPs) and company policies. Collaborating closely with, and under the direct supervision of Senior QC Analytical Chemists, Team Leads and QC Managers, the incumbent develops advanced analytical knowledge and expertise 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 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), 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
• Compiles with all Company policies and procedures, including safety rules and regulations
• Adheres to cGMPs and current Good Documentation Practices (cGDPs)

Minimum education and years of relevant work experience:

Chemist I - Bachelors degree in Chemistry or related science field and minimum 1-5 years lab experience in a cGMP related industry.

Special knowledge or skills needed and/or licenses or certificates required:

• Hands on experience with analytical instrumentation (i.e., UV, IR, HPLC, GC and/or dissolution instruments) in a pharmaceutical or biotechnology setting
• Strong hands on experience performing and interpreting Related Compounds analysis (Impurity analysis)
• Demonstrated ability to apply good laboratory techniques while maintaining efficiencies required in a QC lab
• 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 and willingness to work additional hours as required by business needs
• Excellent ability to identify and distinguish colors

Special knowledge or skills needed and/or licenses or certificates preferred:

• Experience working with Food and Drug Administration (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

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 

Tris Pharma, Inc. offers a highly competitive compensation package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans and women, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-DNI