QC Analytical Senior Chemist

Tris Pharma, Inc. is a privately-owned U.S. biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction. We have a robust pipeline spanning neuroscience and other therapeutic categories and a portfolio of patents and licensed products in the U.S. and abroad. Our team values respectful, open, and honest communication to support individual and team success.

Our Quality Control Department is growing and we have an opening for QC Analytical Senior Chemists I. This is a 1st shift position working Monday–Friday in our Monmouth Junction, NJ laboratories.

• Carries out responsibilities in accordance with company policies, SOPs and applicable laws.
• Performs testing of raw materials, in-process (IP), finished products (FP) and/or stability samples (ST) including dissolution, assay, content/blend uniformity, particle size distribution and other tests according to analytical methods and USP procedures in a regulated laboratory environment.
• Performs analytical method transfers and method verifications.
• Analyzes and interprets test results.
• Operates general analytical instruments during raw material, IP and FP testing such as HPLC, UV/Vis, automatic titration, IR, AA, TLC and dissolution apparatus.
• Assists with identification and troubleshooting of problems with instrumentation and analytical preparations.
• Complies with all company policies and procedures, including safety rules and regulations.
• Adheres to GMPs and current Good Documentation Practices (GDPs).
• Hands-on experience with analytical instrumentation (e.g., UV, IR, HPLC, GC and/or dissolution) 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.

Minimum education and experience: Senior Chemist I — Bachelor’s degree in Chemistry or related science field and minimum 4 years laboratory experience in a cGMP-related industry with increasing technical responsibility.

Special knowledge or skills, licenses/certificates required:

• In-depth hands-on experience with analytical instrumentation in a pharmaceutical or biotechnology setting.
• Experience performing and interpreting analytical results and conducting laboratory investigations.
• Experience with analytical method verifications and method transfers.
• Ability to apply good laboratory techniques while maintaining QC efficiencies.
• Proficiency with Microsoft Office.
• Ability to work independently and collaboratively in a fast-paced, matrixed team environment.
• Analytical thinking and problem-solving skills with the ability to adapt to changing priorities.
• Planning, organization, and time management skills to support multiple projects.
• Fluent in English (verbal and written).
• Ability and/or experience training and mentoring lower-level chemists.
• Ability and willingness to work additional hours as required by business needs.
• Excellent ability to identify and distinguish colors.

• Preferred: Experience with FDA/cGLPs, cGMPs, and SOPs regulatory rules; proficiency with Empower software; wet chemistry experience related to sampling methods, QC systems, analysis, and documentation.

Travel: 0%

• Laboratory-based position.
• Ability to lift up to 30 lbs.
• Ability to use Personal Protective Equipment (PPE).
• Ability to stand for extended periods.

QC Analytical Senior Chemist I — Anticipated Salary range: $85–100k. Base salary is offered based on candidate’s education and experience and related industry standards. Additional benefits include incentives, medical/dental/vision, Rx insurance, 401K with match, life insurance, paid holidays, PTO, Volunteer Time, and Employee Resource Groups.

Tris Pharma, Inc. is an Equal Opportunity Employer. We encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc.