Sr Scientist, Analytical Research & Development
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.
Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Sr Scientist, Analytical Research and Development (AR&D).
Under limited supervision, the Sr Scientist AR&D performs analytical method development, participates as a team member in complex technical investigation efforts, performs highly technical and specialized Analytical Scientist duties, research on assigned problems and studies in support of product development efforts. Some responsibilities include, but are not limited to:
• Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
• May supervise, coordinate, prioritize and lead the daily activities of a group of Analytical Scientists and schedule their workloads.
• Designs experimental plans as per current FDA/ICH guidance; Researches and critically analyzes data and information gathered in support of project directives.
• Performs and may oversee the development of robustness methods for testing of raw materials, IP, FP and ST samples using HPLC, Gas Chromatography (GC), UV/Vis, automatic titrator, IR, AA and TLC and dissolution apparatus.
• Performs/Understands the competitor products to provide information for Product Development and the dissolution testing method of Company and competitor product, the physical characterization of drug substances, excipients and dosage forms.
• Maintains appropriate documentation of records, report sheets and laboratory notebooks as required by SOPs.
• Trouble-shoots/Reviews the test methods and procedures as required.
• Oversees calibrations of laboratory equipment to ensure compliance with SOPs, cGLP and cGMP.
• Provides scientific and technical leadership to junior staff members to ensure project deadlines and performance standards are met; Collaborates closely with management to set priorities and reach objectives.
• Surveys the scientific literature to remain current with developments in analytical chemistry, pharmaceutics, pharmaceutical testing, and adds technical competence.
• Prepares and presents written and oral reports in detail on research findings, project status, literature reviews, and technical issues that affect Company’s business.
• Provides formal and informal training to research staff on technical subjects, administrative procedures and regulatory requirements.
Bachelors degree in Chemistry or related scientific discipline AND minimum 8 years AR&D, Method Validation and/or Method Development experience in pharmaceutical or biotechnology industry in positions of increasing technical and responsibility OR an equivalent combination of education and experience.
Special knowledge or skills:
• In-depth, hands-on experience with analytical instrumentation (UV, IR, HPLC, GC, LC/MS, GC/MS and/or dissolution instruments) in a pharmaceutical, biotechnology or academic setting REQUIRED
• Proficiency with Microsoft Office REQUIRED
• Advanced 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.