MSAT Research Associate II

MSAT Research Associate II

Vacancy expired!

Job Description

This individual will be responsible for performing a variety of functions including analytical testing for release, in-process, stability, and process characterization for our PSS clients Biologics late-stage clinical development and commercial programs in a cGMP compliant manner. Responsibilities will also include reviewing, reporting test results and ensuring that all activities within the laboratory are performed in compliance with cGMP, internal written procedures and policies.

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
  • Transcribe results onto analysis reports
  • 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
• Provide technical guidance to the clients MSAT Analytical group pertaining to analytical testing and instrument troubleshooting.
• Qualify as trainers on test method procedures. Execute and document training. Assist in the creation and implementation of laboratory training programs.
• Execute analytical testing following compendia (USP, EP, JP), and in-house analytical procedures
• Write protocols and execute method verification/validation/qualification/ transfers
• Write, execute laboratory investigations as needed
• Drafting documents (SOPs, specifications, technical reports)
• Execute, oversee instrument qualification as necessary
• Document data as needed utilizing LIMS, ELN, SAP, SLIM and Oracle
• Troubleshooting of technical procedures, methodology and instrumentation

Qualifications

• Minimum BS degree in Chemistry, Biochemistry or related science discipline
• Approximately 3 – 4 years of cGMP laboratory and/or Pharmaceutical Quality experience
• Proficiency in HPLC, KF, pH, UV/Vis Spectroscopy
• Techniques preferred but not required are LC-MS, GC, GC-MS, SDS-PAGE, Capillary Electrophoresis, cell-based potency assays
• Proficiency in LIMS or similar system, Empower, Electronic Notebook (ELN) and lean laboratory operations is preferred but not required
• Proficiency cGMP regulations and laboratory safety procedures
• Proficiency in laboratory instruments/qualification program as necessary
• Ability to react quickly to changes in project priorities and timelines

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