Tris Pharma · 4 hours ago
AR&D Sr. Scientist I
Monmouth Junction, NJ
Full-time
Onsite
Mid, Senior Level
$115K/yr - $135K/yr
3+ years expTris Pharma, Inc. is a leading privately-owned U.S. biopharmaceutical company focused on developing innovative medicines. The Analytical Research and Development Senior Scientist I will perform analytical method development, troubleshoot existing methods, and provide analytical input to support product development projects.
BiotechnologyLife ScienceManufacturingMedicalPharmaceutical
Responsibilities
Carries out responsibilities in accordance with company policies, Standard Operating Procedures (SOPs) and state, federal and local laws
Acts as AR&D lead for assigned development projects liaising with Product Development (PD) department on analytical deliverables
Sets up and operates analytical instruments to support sample testing, including High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultra Violet Visible spectroscopy (UV/Vis), Infrared Spectroscopy (IR), Thin Layer Chromatography (TLC), automatic titration, Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Liquid Chromatography–Mass Spectroscopy (LC-MS) and dissolution apparatus
Performs analytical method development and troubleshooting of existing analytical methods for in process (IP), finished products (FP) and stability (ST) sample testing; Performs and guides laboratory analyses of raw materials, IP, FP and ST samples
Designs and executes physical characterization studies to facilitate product understanding, such as rheological, microscopy, surface area and thermal studies
Designs, guides and performs reverse engineering studies of Reference Listed Drug (RLD) to support Product development
Designs, guides and performs pre-formulation studies (i.e, pH solubility, pH stability, excipients compatibility studies, etc.) in collaboration with PD
Performs trend analysis of development stability results, investigates Out of Specification (OOS) and Out of Trend (OOT) results in support of project directives
Provides analytical input to support complex technical investigations
Documents all testing details and results in laboratory notebooks compliant with current Good Documentation Practices (cGDPs); Prepares analytical method development reports, technical protocols/reports and scientific packages for internal and external use
Creates and reviews ARD SOPs, as needed
Safely and properly disposed of chemical waste, as needed
Cleans, maintains and calibrates laboratory instruments to ensure compliance with current Good Laboratory Practices (cGLPs) and current Good Manufacturing Practices (cGMPs); Cleans and organizes AR&D lab areas
Assists and trains lower level scientists
Performs related duties as assigned
Qualification
Required
Bachelors degree in Chemistry or related science field and minimum 10 years experience in analytical development in the pharmaceutical or biotechnology industry
Masters degree in Chemistry or related science field and minimum 8 years experience in analytical development in the pharmaceutical or biotechnology industry
PhD in Chemistry or related science field and minimum 3 years experience in analytical development in the pharmaceutical or biotechnology industry
Strong knowledge and experience of physical characterization, thermal, spectroscopic and chromatographic techniques and concepts
Hands on experience in setting up and operating multiple analytical instrumentation which may include: UV/Vis, HPLC, GC, TLC, ICP-MS and dissolution apparatus
Strong working experience in designing and executing pre-formulation, analytical and physical characterization studies with high scientific standard
Working knowledge of cGMP, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA) and Occupational Safety and Health Administration (OSHA) regulations and guidance
Strong technical writing skills, including SOPs, investigations, protocols, reports and scientific packages
Ability to train and mentor lower levels scientist
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
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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