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:

Performs data review of all laboratory notebooks, associated documentations, method validation protocols/reports and method transfer protocols/reports to ensure accuracy and any identified errors are properly corrected. Conducts review of all instrument calibration/qualification protocols and reports. Performs review of all new and revised specifications and associated test methods. Reviews and revises SOPs as needed. Required to adhere strictly to company policies and current industry standards and to follow cGMP 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.
• Reviews 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:

• Good working knowledge of HPLC, GC, UV/Vis, automatic Titrator, FTIR, GC-MS, LC-MS, ICP-MS and Dissolution.
• Experience with Empower chromatographic data acquisition software as well as Microsoft Excel.
• Ability to work collaboratively in a fast paced, matrixed, team environment.
• Ability to abide to company policies, practices and procedures, including cGMP, GDP and SOP requirements.
• Good verbal and written communication skills.
• Working knowledge of FDA and cGMPs regulations and guidances.
• Good planning, organization and time management skills including the ability to support and prioritize multiple projects.

Required Behavior:

• Action oriented and motivated, with a sense of urgency and enthusiasm.
• Focus on performance, quality and excellence, and willing to go above and beyond.
• Innovative, keen on finding new and better ways to be successful.
• Adaptive to changes.
• Learning driven and keen to self develop.
• Hold self accountable to meet commitments.
• Collaborative, team player.
• Transparent and authentic.
• Adheres consistently to high ethical principles, integrity, and professional standards.

Minimum 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 industry.