Senior Scientist I (Product Development) for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc. Carry out responsibilities in compliance w/ orgs policies + procedures + CGMP, FDA, DEA, + OSHA regs. Design, plan + conduct prod dev activities incl pre-formulation, formulation, process development, + scale up studies of complex projects to ensure sci standards met. Document study details in lab notebooks + batch records compliant w/ GDP + CGMP. (A complete list of duties can be found at trispharma.com/connect/careers). May undergo background checks incl drug screen. Must have Bach in Pharm, Pharm Sci, or rel sci field, 10 yrs rel exp in pharmaceutical formulation and product development, and required skills (10 yrs exp). In the alternate, must have Masters in Pharm, Pharm Sci, or rel sci field, 8 yrs rel exp in pharmaceutical formulation and product development, and required skills (8 yrs exp). Alternatively, must have PhD in Pharm, Pharm Sci, or rel sci field, 3 yrs rel exp in pharmaceutical formulation and product development, and required skills (3 yrs exp). Required skills: designing and conducting pharmaceutical formulation and process development studies with high scientific standard of multiple dosage forms, including oral controlled release solids; using Quality-by-Design and risk-based approaches; working with FDA and CGMP regulations and guidance, and OSHA requirements; technical writing, including SOPs, investigations, protocols, reports and submission documents; training and mentoring lower level scientists; and Microsoft Office. All candidates also must have 6 months exp handling controlled substances. Any suitable combination of education, training, or experience is acceptable. Apply at trispharma.com/connect/careers
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