QA R&D Chemist I

About the role

Located in Monmouth Junction, New Jersey, Tris Pharma has an immediate opening for a QA R&D Analytical Chemist, I. 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.

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

Minimum Education and 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

Required Skills

• 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 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

Preferred Skills

• 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

Work Environment

• Laboratory based position
• Ability to use Personal Protective Equipment (PPE)
• Ability to stand for extended periods of time
• Travel requirements: 0%

Pay

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.

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.