QA R&D Chemist I

Tris Pharma, Inc. () is a leading privately-owned U.S. biopharmaceutical company with a focus 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 also 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 science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and 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 QA R&D Analytical Chemist, I

SUMMARY:

The Quality Assurance (QA) Research and Development (R&D) Chemist I supports Quality Control (QC) and Analytical R&D (AR&D) activities by initiating appropriate change controls and updating specifications to reflect changes in methods. Analytical support activities include, but are not limited to: method improvements, system equivalency, transfers, verifications, alternate source qualifications and authoring residual solvent, elemental impurity and nitrosamine risk assessments, as directed by R&D. The incumbent may also perform additional responsibilities including laboratory analyses of raw materials, in-process (IP) testing, finished products (FP), stability (ST) sample testing and analytical instrumentation maintenance and calibration.

ESSENTIAL FUNCTIONS

• Carries out responsibilities in accordance with company policies, Standard Operating Procedures (SOPs) and state, federal and local laws
• Creates, reviews or revises SOPs, methods, specifications, verification protocols, reports and change control requests, as needed; Performs vendor qualification for raw materials and packaging materials
• Performs testing of raw materials, packaging components, 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), Malvern Mastersizer, Thin Layer Chromatography (TLC) and dissolution apparatus (Distek)
• Collaborates closely with R&D for analytical method transfer studies and other analytical method related issues
• Assists with the identification and troubleshooting of problems with instrumentation and analytical preparations
• 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 policies and procedures, including safety rules and regulations
• Adheres to GMPs and GDPs
• Any other QA R&D related tasks assigned by Supervisor or QA R&D Management

Requirements

QUALIFICATIONS

Minimum education and years of relevant work experience

Bachelors degree in Chemistry or related science field and minimum 3 years lab experience in a cGMP related industry OR Masters degree in Chemistry or related science field and minimum 1 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, UPLC, Malvern Mastersizer, GC and/or dissolution instruments) in a pharmaceutical, biotechnology or academic setting
• Proficiency with Microsoft Office
• Verbal and written communication and skills
• 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 to identify and distinguish colors
• Ability and willingness to work additional hours as required by business needs

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

• Experience working with Food and Drug Administration (FDA), International Council on Harmonisation (ICH) guidelines, cGMPs and SOPs regulatory rules, regulations and guidelines
• Proficiency with Empower software and other laboratory software
• Experience with wet chemistry and chemistry related to sampling methods, quality control systems, analysis and documentation practices and procedures
• Prior experience working in a QC lab

Travel requirements

0%

Physical requirements

Laboratory based position

• Ability to use Personal Protective Equipment (PPE)
• Ability to stand for extended periods of time

Anticipated salary range: $85k - 95k. Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

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