MSAT Research Associate

MSAT Research Associate

Vacancy expired!

Job Description

This individual will be responsible for performing release, in-process, stability, and process characterization testing for our PSS client’s Biologics late-stage clinical development and commercial programs in a cGMP compliant manner. This position will perform all activities according to approved written procedures or protocols. Additional responsibilities may include revision to SOPs, method validations, method transfers, and comparability assessments or bridging activities with new analytical methods required for INDa and BLA.

Essential Duties & Responsibilities

• Perform testing in accordance with written procedures for: drug substance and drug product clinical trial materials (bulk or packaged), stability samples, in-process samples, drug substance and drug product process characterization studies.
  • Documentation of laboratory activities including worksheet/notebook entries according to procedures that define laboratory documentation practices
  • Processing of electronic data using procedures that ensure data integrity and security
  • Ship samples to contract testing facilities
  • Review and countersign (when necessary) logbooks, notebooks, and worksheets for the purpose of verifying compliance with written procedures, good documentation practices, data integrity and accuracy of calculations
  • Transcribe results onto analysis reports
  • Perform daily standardization and performance verifications on laboratory equipment
  • Comply with site wide procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety, and electronic data security
  • Identify deviations to written procedures. Write deviation investigation reports
  • Disposal of laboratory waste on an as needed basis
  • Identify and report unsafe conditions within the laboratory
• Identify OOS results, atypical results, and atypical laboratory events requiring a laboratory investigation. Perform investigative testing and write investigation reports
• Write and review equipment qualification documentation
• Qualify as trainers on test method procedures. Execute and document training. Assist in the creation and implementation of laboratory training programs.
• Troubleshoot to ensure quality objectives are met

Qualifications

• Bachelor's degree in Chemistry, Biochemistry or related scientific field
• 1 - 2 years oflaboratory experience in a regulated environment
• Ability to perform routine analysis and operate laboratory equipment. Techniques preferred but not required are: HPLC, GC, SDS-PAGE, Capillary Electrophoresis, Karl Fisher, UV-Vis Spectrometry, and pH measurements
• Understands paperwork review process
• Practical experience with various types of laboratory instrumentation
• Troubleshooting skills with analytical methodology and instrumentation

Additional Information

Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Wimington, OHare encouraged to apply.

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays