QA R&D Chemist I

Tris Pharma, Inc.; New Jersey; On-site; USD 85,000 - 95,000; Full time

Benefits offered by this job

bonus eligible

medical

dental

vision

Rx insurance

401K with match

life insurance

paid Company Holidays

PTO

Paid Volunteer Time

Employee Resource Groups

Job summary

Tris Pharma, Inc. in Monmouth Junction, New Jersey, is seeking a QA R&D Analytical Chemist I to support QC and AR&D activities in a cGMP environment.

The role includes method improvements, verification, change controls and residual solvent, impurity and nitrosamine risk assessments using HPLC/UPLC, GC and UV/Vis. Candidates should hold a Bachelors in Chemistry with 3+ years in a cGMP lab or a Masters with 1+ year, be fluent in English, and capable of independent and collaborative work.

Qualifications

• Bachelor's degree in Chemistry or related science field with 3+ years in a cGMP lab.
• Master's degree in Chemistry or related field with 1+ year in a cGMP lab.
• Hands-on experience with analytical instrumentation in pharma settings.
• Proficiency with Microsoft Office.
• Fluent in English (written and verbal).
• Ability to work independently and in a fast-paced, matrixed team.
• Ability to identify and distinguish colors.
• FDA/ICH guidelines familiarity preferred.

Responsibilities

• Perform testing of raw materials, IP, FP and ST samples according to methods.
• Prepare and revise SOPs, specifications, verification protocols and change controls.
• Assist with method transfers and risk assessments for residual solvents and impurities.
• Operate instruments (HPLC/UPLC, GC, UV/Vis, IR, dissolution) in a regulated lab.
• Collaborate with R&D on analytical method transfer studies and issues.
• Maintain lab cleanliness and safety compliance.

Skills

Analytical instrumentation

Microsoft Office

Communication skills

Team collaboration

Analytical thinking

Time management

English fluency

Color vision

Willingness to work extra hours

cGMP knowledge

Education

Bachelor's in Chemistry

Master's in Chemistry

Tools

HPLC/UPLC

GC

UV/Vis

IR

Malvern Mastersizer

Dissolution tester

Empower software

Job description

Description

Tris Pharma, Inc. (www.trispharma.com) 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:

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:

• bonus eligible
• medical
• dental
• vision
• Rx insurance
• 401K with match
• life insurance
• paid Company Holidays
• PTO
• Paid Volunteer Time
• 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-_