UPM Pharmaceuticals, a Division of Gregory Pharmaceutical Holdings, Inc., (www.upm-inc.com) located in Bristol, Tennessee, is seeking a Senior Scientist that leads in the development of new analytical methods and mentors other analysts to develop their technical skills.
Essential Duties and Responsibilities:
Performs analytical method transfer, optimization, and development/validation design and analytical methods development/validation of drug substances, drug product and residual testing, using guidelines from USP and ICH. Plays a lead role in the development of new methods. Develops protocols under which the methods transfer, optimization, and development are conducted. Evaluates statistically the validation data and writes the method validation report for submission. Writes, edits, and revises test methods and procedures into company SOPs; reviews, writes, or assists in writing SOPs for analytical development. Participates in the planning and execution of raw material, components, and vendor qualification or alternate supplier qualification studies. Participates in laboratory investigations and assists in writing investigation reports. Performs USP Compendial testing and other Compendial testing as required. Consults with scientific professionals and scientific literature for problem solving assistance. Provides analytical testing support for manufacturing process validation. Documents laboratory activity and files all data using appropriate log books, records, files, and equipment calibration logs. Observes safety rules and assists in keeping the laboratory a safe environment. Operates laboratory equipment such as balances, pH-meters, hardness testers, and dissolution baths in the performance of required and scheduled test procedures and in accordance with laboratory SOPs. Performs routine sample processing and dosage form analysis using HPLC, Dissolution and UV-Vis analysis equipment. Performs routine maintenance, calibration, and performance verification on applicable instruments. Conducts peer reviews of other analytical chemists and scientist’s work prior to submission to quality assurance. Maintains professional and scientific competence in analytical chemistry by reading scientific literature and/or attending seminars, training sessions, workshops or classes.
Bachelor’s degree in Chemistry or related scientific field with at least 8 years of analytical chemistry experience. Advanced degree preferred. Pharmaceutical laboratory experience in analytical methods development and validation is required. Equivalent combination of education and experience or training is acceptable. Knowledge of company laboratory SOPs, good laboratory practices, cGMP practices, USP methodology, FDA, ICH, OSHA, and DEA regulations, and MSDSs essential. Should possess basic computer skills with knowledge of Word, Excel, Access, Outlook and the ability to use internet tools.
Qualified candidates please reference job title and email resume and salary requirements to:
email@example.com or fax: 423-989-8042. EOE.
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