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Post Date: 11/17/2017 Job ID: 160672 Industry: Professional

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.


Kristi Kelley, CSP

Kristi began her AtWork career in November 2012 as an Administrative Assistant. She was promoted to Staffing Manager in October 2014.

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