Tris Pharma · 11 hours ago
Method Validation Scientist II
Monmouth Junction, NJ
Full-time
Onsite
Entry, Mid Level
$85K/yr - $100K/yr
2+ years expTris Pharma, Inc. is a leading privately-owned U.S. biopharmaceutical company focused on innovative medicines in ADHD and other therapeutic areas. The Method Validation Scientist II will perform laboratory analyses for various samples, prepare protocols, and support laboratory investigations to ensure compliance with industry standards.
BiotechnologyLife ScienceManufacturingMedicalPharmaceutical
Responsibilities
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
Qualification
Required
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
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
Benefits
Incentives
Bonus eligible
Medical
Dental
Vision
Rx insurance
401K with match
Life insurance
Paid Company Holidays
PTO
Paid Volunteer Time
Employee Resource Groups
Company
Tris Pharma
Tris Pharma is a pharmaceuticals company providing specialty generic products.
501-1000 employees
H1B Sponsorship
Tris Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (18)
2024 (21)
2023 (20)
2022 (17)
2021 (16)
2020 (33)
Funding
Current Stage
Late StageTotal Funding
$141.6MKey Investors
National Institute on Drug Abuse (NIDA)Deerfield
2023-08-28Grant· $16.6M
2018-10-05Debt Financing· $125M
Leadership Team
Franchesca M. Fowler
General Counsel, Sr. Vice President and Chief Compliance Officer
J
James Hackworth
President, Brand Division
Recent News
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