Method Validation Scientist II

Description

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We 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 our team members set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success.

Our R&D Method Validation lab is located in our Monmouth Junction, NJ headquarters has an immediate need for an experienced Method Validation Scientist II.

Summary:

The Method Validation (MV) Scientist II, 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 Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs) procedures. The incumbent prepares MV protocols/reports, and carries out MV activities, including interim method validation to meet project timelines, tracking and maintaining sample flow, supports laboratory investigations and performance of non-routine testing (i.e., method comparisons and evaluations, etc.).

Essential Job Functions:

* Carries out responsibilities in accordance with company policies, SOPs, and state, federal and local laws

* Sets up and operates analytical instruments (i.e., High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultra Violet Visible spectroscopy (UV/Vis), Infrared Spectroscopy (IR), Atomic Absorption (AA), Thin Layer Chromatography (TLC), dissolution apparatus, etc.) to support sample testing

* Performs laboratory analyses of raw materials, IP, FP and ST samples; Prepares standard and sample solutions as required by test methods

* Performs wet chemistry tests such as Loss on Drying (LOD), Water Content (KF Titrator), pH and titration

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

* Performs all necessary calculations associated with test analyses

* Labels, transcribes and records all testing details and results in laboratory notebooks and report sheets, compliant with current Good Documentation Practices (cGDPs), cGMPs and SOPs

* Cleans, maintains and calibrates laboratory instruments to ensure compliance with current Good Laboratory Practices (cGLPs) and cGMPs; Cleans and organizes MV lab areas

* Creates MV SOPs, as needed

* Safely and properly dispose of chemical waste, as needed

* Prepares MV/verification protocols and reports

* Performs qualitative and quantitative analysis to support reference standard qualifications, method validation, method comparisons and transfers

* Performs investigations, evaluates and verifies compendial methods

* Tracks and maintains sample flow

* Performs related duties, as assigned

Requirements

Minimum education and years of relevant work experience

Bachelors degree in Chemistry or related science field and minimum 4 years experience in analytical development and/or MV in the pharmaceutical industry OR Masters degree in Chemistry or related science field and minimum 2 years experience in analytical development and/or MV in the pharmaceutical industry OR PhD in Chemistry or related science field with 0-1 years experience in analytical development and/or MV in the pharmaceutical, biotechnology and/or academic research field.

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

* Understanding of spectroscopic and chromatographic techniques and concepts

* Hands on experience in setting up, operating and troubleshooting multiple analytical instrumentation which may include: UV, IR, HPLC, LC-MS, GC, GC-MS, ICP-MS, TLC and dissolution apparatus

* Working knowledge of cGMP, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA) and Occupational Safety and Health Administration (OSHA) regulations and guidances

* Knowledge of method validation parameters and relevance in method performance

* Strong understanding of Quality Assurance (QA)/Quality Control (QC) systems, including change control systems

* Ability to perform analytical testing, calculations and data analysis as instructed

* Ability to perform wet chemistry and physical testings as instructed

* Proficiency with Microsoft Office

* 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 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)

* Ability to identify and distinguish colors

Anticipated salary range: $85k - 100k. Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

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-_