This job has expired

You will need to login before you can apply for a job.

Method Validation Reviewer

Employer
Tris Pharma
Location
Monmouth Junction, NJ
Start date
Sep 16, 2023

View more

Discipline
Information Technology, Science/R&D, Biotechnology, Chemistry
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country

Job Details

  

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.

Requirements

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. 

Company

Founded in 2000, Tris Pharma, Inc. (www.trispharma.com) is the 3rd largest specialty pharmaceutical company in the United States. With our intense focus on the application of physical chemistry in biological systems, coupled with the requirements of manufacturing and market demands, we have grown our employee base over 250% in the past three years. Specifically, we are engaged in research, development, and manufacturing of both OTC and Rx branded products and specialty generic products. Our mission is to understand the science driving the delivery of drugs into the human body;develop and bring to market products that add value to our customers and patients and provide a benefit to our company, employees and society at large.

Company info
Website
Telephone
(732) 940-2800
Location
US Highway 130
Monmouth Junction
NJ
08852
US

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert