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Method Validation Scientist II
4 months ago
Tris Pharma, Inc. ) 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.
Our Method Validation Department located in our Monmouth Junction, NJ headquarters has an immediate need for an experienced Method Validation Scientist II.
Summary:
Under supervision, performs laboratory analyses of raw materials, in process (IP), finished products (FP) and stability (ST) samples for pilot and submission batches, according to SOPs and cGMP procedures. Prepares method validation protocols/reports, and carries out method validation activities, including interim method validation, to meet project timelines. Supports laboratory investigations and performance of non-routine testing such as method comparisons and evaluations. Tracks and maintains sample flow. Required to adhere strictly to company policies and current industry standards.
Essential Job Functions:
Requirements
Minimum Qualifications: Bachelor's Degree in Chemistry or related scientific field, with at least five (5+) years, or Master's Degree in Chemistry or related scientific field, with at least three (3+) years of experience in analytical development and/or method validation in the pharmaceutical field.
Required Knowledge, Skills and Experience:
Proficiency with Empower Software