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Form of workDescription
Sr. Scientist I, Method Validation, for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc. Performs analytical Method Validation, participates as a team member in complex technical investigation efforts, performs highly technical and specialized Analytical Scientist duties, performs laboratory analyses in the testing of raw materials for release, in process (IP), finished products (FP) during process validation and stability (ST) samples of test batches if needed. Performs and may oversee the validation of analytical methods for raw materials, IP, FP and ST samples using HPLC, UPLC, Gas Chromatography (GC), UV/Vis, automatic titrator, IR, AA and TLC and dissolution apparatus. Conduct and document chemical and physical tests of API, finished products, such as development of dissolution, assay and impurity methods, including pH stability and solubility study. Maintain approp doc of records, report sheets and lab notebooks as reqd by SOPs. Rev + eval compendial methods and proced. Write tech reports in response to FDA queries. Oversee calib of lab equip to ensure compliance with SOPs, cGLP and cGMP. Provide sci leadership to jr staff members. Collab with mgmt. to set priorities + reach objs. Prep valid protocol, valid reports, specs, investigation & non- conformance reports + other tech docs. Monitor timelines for investigations, stab testing + change control activs. Provide formal + informal training to research staff on tech subjs, admin proceds + reg reqs. Ensure compliance w/ company policies, proceds incl safety rules + regs. May undergo background checks incl ref checks and drug screen.
Requirements
Must have Master's degree in Chemistry, Pharm, or rel field and 2 yrs rel lab testing exp; or Bach degree in Chemistry, Pharm, or rel field and 5 yrs rel lab testing exp. Also req skill (2 yrs exp) in: cGLP or cGMP lab environment working with pertinent pharm SOPs for lab testing, analyses, and documentation; performing or overseeing validation for dissolution, assay, impurity, cleaning and residual solvent method of API and finished products, using HPLC, UV/IR, gas chromatography, TLC and dissolution apparatus as well as methods and techniques, including specificity, precision, accuracy, forced degradation, LOQ, LOD, stability and robustness; method development for API and finished products - including dissolution, assay and impurity methods and stability (pH and solubility), Empower 3; chemical and physical testing of API, finished products, in-process products and stability samples which include assay, impurity, dissolution, residual solvent and cleaning per FDA and GMP guidelines; and chemistry, pharmaceutical and statistical theories, methods and procedures.
