Method Validation Scientist

3 weeks ago

Monmouth Junction, New Jersey, United States Tris Pharma Full time

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.

We have immediate openings in Monmouth Junction, NJ for MV Scientists.

Under supervision, MV Scientists:

· Perform testing, analytical method validation and transfer activities of raw materials, in process (IP) and finished products (FP) samples to support Technical Services (TS) submission batches, according to SOPs and cGMP procedures

· Prepare method validation protocols/reports to meet project timelines

· Perform technical and specialized analytical tasks to support method validation, method transfer and technical investigations

· Supports extractables/leachables, nitrosamine impurity and elemental impurity studies

· Are required to adhere strictly to company policies and current industry standards.

Essential Job Functions:


• Sets up and operates instruments including (but not limited to) HPLC, LC-MS, GC, GC-MS, ICP-MS, UV/Vis, Automatic titration, IR, AA, TLC and dissolution apparatus to support sample testing.


• Performs testing, analytical method validation and transfer activities of raw materials, in process (IP) and finished products (FP) samples. Prepares standard and sample solutions as required by the test methods.


• Performs wet chemistry tests such as LOD, pH, and titration.


• Performs physical tests including thermal analysis, particle size, viscosity, and density measurements.


• Supports extractables/leachables, nitrosamine impurity and elemental impurity studies.


• Performs all necessary calculations associated with test analyses.


• Cleans, maintains and calibrates laboratory instruments to ensure compliance with cGLP and cGMP.


• Performs qualitative and quantitative analysis to support reference standard qualifications, method comparisons and transfers.


• Performs complex investigations and assists in identification of CAPAs/CPIs and prepares method validation/verification protocols, SOPs and reports.

Requirements

REQUIRED QUALIFICATIONS

Bachelor's Degree in Chemistry or related scientific field, with minimum 3 years experience OR Master's Degree in Chemistry or related scientific field, with minimum 2 years experience in method validation in the pharmaceutical field. Title and level commensurate with experience.


• Knowledge and experience of spectroscopic and chromatographic techniques and concepts.


• Hands-on experience in setting up and operating any/all of following equipment: LC-MS, GC, GC-MS, ICP-MS.

· Hands-on experience in setting up and operating UV/IR, HPLC, TLC and dissolution apparatus.


• Working knowledge of FDA and cGMPs regulations and guidances as well as DEA and OSHA requirements.


• Strong knowledge of qualitative and quantitative method validation parameters and their relevance in method performance.


• Strong technical writing skills, including SOPs, investigations, protocols and reports.


• Strong understanding of QA/QC systems, including change control systems.

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. #LI-DNI PM22

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