Seeking an Analytical Development Chemist that leads in the development of new analytical methods and mentors other analysts to develop technical skills for a great company in Bristol, TN.
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 analytical qualification studies.
- Participates in laboratory investigations and assists in writing investigation reports.
- Performs USP Compendia testing and other Compendia 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 5 years of analytical chemistry experience.
- Pharmaceutical laboratory experience in analytical methods development and validation is desirable.
- Equivalent combination of education and experience or training is acceptable.
- Knowledge of good laboratory practices, cGMP practices, USP methodology, FDA, ICH, OSHA, and DEA regulations, and MSDSs.
- Should possess basic computer skills with knowledge of Word, Excel, Access, Outlook and the ability to use internet tools.
- Empower Chromatography software experience is valuable.
Apply today by clicking on the link below, then contact Kristi at 423-764-1334.