Scientist, Laboratory Technical Services

Analytical Scientist

Validates analytical methods for finished product and raw material release and stability testing. Evaluates, troubleshoots/improves existing analytical methods when necessary. Prepares method validation protocols, reports, and analytical test methods. Performs testing to support process and formulation development (e.g. excipient compatibility, solubility, dissolution studies, stability/impurity assessment). Performs work to support project as assigned with little oversight. Presents analytical data to project team for review and discussion. Reviews and approves laboratory test data and documentation (e.g. notebooks, raw data and technical documentation, test method, validation protocol, or validation report) for completeness and compliance when necessary. Reviews and evaluates drug substance supplier's technical documents to ensure internal test requirements are adequate. Uses laboratory software for analyses. Is alert to and detects abnormalities during performances of tests and reviews. Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping. Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals. Troubleshoots instrumentation and performs subsequent analyses. Elevates questionable sample results, OOS, and aberrant results immediately to supervisor and recommends a course of action related to LTS activities. Participates in root cause identification of complex laboratory investigations. Writes, edits, and reviews SOPs and laboratory investigations. Trains junior scientists/chemists on analytical techniques. Continuously updates knowledge with respect to the latest technologies related to analytical science. Maintains assigned training records current and in-compliance. Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and procedures. Identifies need for SOPs and writes or revises, as appropriate. Performs work in a timely and safe manner conforming to regulatory, company and compendial requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations. Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs. Takes active role in auditing laboratory logbooks/documentation to ensure compliance. Follows internal processes related to controlled substances. Follows EH&S procedures to ensure a safe work environment. Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.

Education: Master Degree in Pharmaceutical Science or related major. Foreign academic equivalence acceptable.

Experience: Six months experience in the job offered, Chemist or related.

Required Skills: Experience with Dissolution Apparatus, pH meter, UV-Visible spectrophotometer, Analytical Balance.