Chemist - Full-time / Part-time

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.

Education/Experience:

• 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.

EOE