Method Validation Reviewer

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and 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 it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other and we believe in respectful, open and honest communications to help support individual and team success.

MV Data Reviewer Position: 

The Method Validation (MV) Research and Development (R&D) Data Reviewer performs review of all laboratory notebooks, associated documentations, MV protocols/reports and method transfer protocols/reports to ensure accuracy and proper correction of identified errors. The incumbent conducts review of all instrument calibration/qualification protocols and reports, all new and revised specifications and associated test methods. She/he also reviews and revises Standard Operation Procedures (SOPs).

Essential Job Functions: 

· Carries out responsibilities in compliance with all cGMP and FDA regulations, as well as all applicable company compliance guidelines, policies, standards and objectives. 

· Reviews all data generated and recorded in laboratory notebooks and associated documentations to ensure accuracy and any identified errors are properly corrected.

· Reviews and revises applicable SOPs as needed.

· Reviews and evaluates compendial procedures as needed.

· Reviews all instrument calibration/qualification protocols and reports.

· Reviews method validation protocols and reports.

· Reviews analytical method transfer protocols and reports and new and revised specifications and associated test methods.

· Collaborates closely with MV management to set priorities and reach objectives.

· Performs related duties as assigned.

Required Knowledge, Skills and Experience:

Minimum Education Qualifications: Bachelor’s Degree in Chemistry or related scientific field with at least eight (8+) years, or Master’s Degree in Chemistry or related scientific field with at least five (5+) years of experience in analytical development or method validation in the pharmaceutical or biotechnical industry

Special Knowledge of skills needed, and or/licenses or certification required

·  Good working knowledge of multiple analytical instruments which may include High-Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultra Violet Visible spectroscopy (UV/Vis), automatic Titrator, Fourier-transform Infrared spectroscopy (FTIR), Gas Chromatography- Mass Spectroscopy (GC-MS), Liquid Chromatography- Mass Spectroscopy (LC-MS), Inductively coupled plasma mass spectrometry (ICP-MS) and dissolution apparatus

· Experience with Empower software

· Working knowledge of cGMP, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA) and Occupational Safety and Health Administration (OSHA) regulations and guidances

· Experience with Microsoft Office, including Excel

· Ability to work 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) 

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.