QC Analytical Senior Chemist

Overview

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 addressing unmet patient needs. We have >150 US and international patents and market several branded ADHD products in the U.S. We license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our team emphasizes respectful, open and honest communications to support individual and team success.

Our Quality Control Department is growing and we have an opening for QC Analytical Senior Chemist 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 state, federal and local 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 (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 in a QC lab

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

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

• In-depth, hands-on experience with analytical instrumentation (UV, IR, HPLC, GC and/or dissolution) in a pharmaceutical or biotechnology setting
• Experience performing and interpreting analytical results and laboratory investigations
• Experience with analytical method verifications and method transfers
• Ability to apply good laboratory techniques while maintaining QC efficiency
• Proficiency with Microsoft Office
• Ability to work independently and collaboratively in a fast-paced, matrixed, team environment
• Analytical thinking and problem-solving skills with ability to adapt to changing priorities and deadlines
• Planning, organization and time management skills for multiple projects
• Fluent in English (verbal and written)
• Ability and/or experience training and mentoring lower level chemists
• 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 and guidelines
• Proficiency with Empower software
• Experience with wet chemistry and sampling methods, quality control systems and related documentation practices

• Travel: 0%
• Physical:
  Laboratory-based position; ability to lift up to 30 lbs; ability to use PPE; ability to stand for extended periods

Anticipated Salary range: $85,000–$100,000. Base salary offered is contingent on assessment of education and experience relative to requirements and industry standards. Benefits include incentive opportunities, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid 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.