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.

Position Summary:

The Method Validation Documentation Specialist supports the Method Validation (MV) department by creating, revising, and organizing all new and revised specifications and associated test methods and documents in compliance with Management of Change system and following Standard Operating Procedures (SOPs) under current Good Manufacturing Practices (cGMPs) and company policies.

The incumbent is also responsible for preparation, revising, and maintenance of other departmental documentation including, but not limited to: annual reports, SOPs, raw material qualification reports, risk assessments reports, release and stability specifications, outside contract laboratory reports, etc

Essential Functions/Responsibilities

• Carries out responsibilities in accordance with company policies, SOPs and state, federal and local laws; Adheres to cGMPs and current Good Documentation Practices (cGDPs)
• Creates all new and revised specifications and associated test methods and specifications in compliance with Management of Change system
• Prepares annual reports for commercial products and supports documents for submission
• Performs compendial review for Research and Development (R&D) projects
• Prepares and assembles raw material qualification reports for commercial products
• Supports documents for submission, elemental impurity risk assessment reports, nitrosamine risk assessment reports for drug products
• Organizes and maintains an in-house archiving system for laboratory notebooks, logbooks, data packs, method validation reports and other appropriate scientific documentation; Enters results in release and stability specifications
• Reviews and revises applicable SOPs, as needed

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Minimum education and years of relevant work experience

Bachelors degree in science field and minimum 8 years experience in analytical development or method validation in the pharmaceutical or biotechnology industry OR Masters degree in science field and minimum 5 years experience in analytical development or method validation in the pharmaceutical or biotechnology industry.

Special knowledge or skills needed and/or licenses or certificates required

• Hands on experience with analytical instrumentation (i.e., Ultra Violet visible spectroscopy (UV/Vis), High-Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC), Gas Chromatography-Mass Spectroscopy (GC-MS), Liquid Chromatography-Mass Spectroscopy (LC-MS), Inductively Coupled Plasma Mass Spectroscopy (ICP-MS) and dissolution instruments) in a pharmaceutical or biotechnology industry
• Hands on experience with Empower chromatographic data acquisition software
• Excellent working knowledge of FDA, cGMPs, cGDP regulations and guidance
• Proficiency with Microsoft Office
• Excellent 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 excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent 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.