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Analytical Research & Development Sr. Supervisor

Employer
Tris Pharma
Location
Monmouth Junction, NJ
Start date
Jun 17, 2024

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Job Details

 Analytical Research & Development Sr. Supervisor for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc. Independently perf daily asgmts following org’s policies + procedures, + state, fed + local laws. Design practical rsrch expts based on lit., vendor DMF, + FDA guidance to support pjct directives. Perf + hold others accountable to dev methods to test raw materials, IP, FP + ST samples using HPLC, Gas Chromatography (GC), UV/Vis, automatic titrator, IR, AA and TLC + dissolution apparatus. Provide recs to Prod Dvlpmnt based on dissolution testing + phys characterization of Company + competitor prods. Troubleshoot existing test methods + procedures. Assess jr staff members re sci + tech capabilities. Work w/ mngmnt to set priorities + reach objectives. Ensure analytical procedures align w/ current compendial + FDA guidance. Introduce new analyt techniques to lab. Operate gen analytical instruments during raw material, in process + finished product release + stability testing. Perf wet chemistry tests. Prep standard + sample sols, + perf calculations associated w/test analyses. May involve extended periods of standing and lifting up to 30 pounds. May undergo background checks and drug screening.  

Requirements

 Must have Bach in Analytical Chem, Chem, or rel field, 4 yrs rel exp working in analytical lab in pharmaceutical industry, and required skills. In the alternate, must have Masters in Analytical Chem, Chem, or rel field, 3 yrs rel exp working in analytical lab in pharmaceutical industry, and required skills. Required skills: (3 yrs exp) in: operation and interpretation of data generated from usage of analytical instruments such as HPLC, LC/MS, GC/MS, NMR, FTIR, and ICP-MS; preparation, extraction, purification of Wet Chemistry testing samples; SOPs related to pharmaceutical laboratory testing, analyses, and documentation; UV/IR, HPLC, GC, TLC, and dissolution testing instruments operations, methods, and techniques; following FDA, cGLP, cGMP, and SOP regulatory rules, regulations, and guidelines; advanced chemistry, pharmaceutical and statistical theories, methods and procedures; calibration and troubleshooting LC/MS, GC/MS, and ICP-MS, GFAA, NMR in testing and characterization of organic and inorganic compounds; responding to regulatory agency inquires; training and mentoring junior staff, including coordinating and reviewing work; technical report writing; and ensuring compliance with internal policies and procedures.  Any suitable combination of education, training, or experience is acceptable.  

Company

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.

Company info
Website
Phone
(732) 940-2800
Location
US Highway 130
Monmouth Junction
NJ
08852
US

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