TRIS PHARMA, INC – $105,629.00/Year

JOB REQUIREMENTS Further to Section H above Must have Masters 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, UVIR, 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, inprocess 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.br br BUSINESS NECESSITY Further to H.12 All job opportunity requirements are normal except that the minimum requirements for this job appear to exceed the typical requirements per the OES Job Zone 4 definition. The job requirements are absolutely necessary for this particular type and level position, because a Sr. Scientist I, Method Validation is a senior, specialized position within our structure, and conducts high level technical work using stateoftheart tools and technologies. The work involves complex skills that require employees in this position to hold significant relevant qualifications. The position involves strong analytical duties, high level communications, and the use and development of sophisticated technologies, as well as knowledge of a variety of applicable policies, procedures, regulations, and laws. Such abilities only come with the required minimum level of qualifications. The job requirements bear a reasonable relationship to the occupation of Sr. Scientist I, Method Validation in the context of our business, and the requirements are essential to perform the job in a reasonable manner.