Method Validation Scientist - ALL LEVELS
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.
To support expectations of continued growth Tris is expanding the Laboratories at our Monmouth Junction, NJ facility and has openings for all levels of experienced Method Validation (MV) Scientists.
- MV Scientists perform method validation studies to support testing of raw materials, in process (IP), finished products (FP) and stability (ST) samples of test batches.
- Carries out responsibilities in accordance with the organization’s policies, Standard Operating Procedures (SOPs), and state, federal and local laws
- Operates general analytical instruments during raw material, IP and FP testing such as High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC,), Ultra Violet visible spectroscopy (UV/Vis), automatic titration, Infra Red Spectroscopy (IR), Atomic Absorption ( AA), Thin Layer Chromatography (TLC) and dissolution apparatus
- Performs wet chemistry tests such as loss on drying (LOD), pH, and titration; Performs physical testing (i.e., viscosity and density measurements, etc.)
- Labels, transcribes and records documentation such as report sheets and laboratory notebooks as required by SOPs
- Collaborating closely with the Metrology department, cleans, maintains and calibrates laboratory equipment to ensure compliance with current Good Laboratory Practices (cGLPs) and current Good Manufacturing Practices (cGMP)
- Assists with the investigations and method validation
- Carries out quantitative and qualitative analyses during method validation
Bachelors degree in Chemistry or related scientific field AND MINIMUM 1 year Method Validation experience in pharmaceutical or biotechnology industry. Job title and level determination will be based on education and years of experience.
- Strong hands-on experience with analytical instrumentation (UV, IR, HPLC, GC and/or dissolution instruments) in a pharmaceutical, biotechnology or academic setting REQUIRED
- Strong hands-on experience performing method validation studies to support testing of raw materials, in process (IP), finished products (FP) and/or stability (ST) samples of test batches REQUIRED
- Proficiency with Microsoft Office REQUIRED
- Proficiency with Empower PREFERRED
- MS degree PREFERRED
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.