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Bio-Analytical Scientist
Bio-Analytical ScientistArtech LLC • East Syracuse, NY
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Bio-Analytical Scientist

Bio-Analytical Scientist

Artech LLC • East Syracuse, NY
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12 months contract

100% onsite

Duties / Responsibilities :

  • Develop, author, and peer review standard operating procedures, analytical methods, protocols, reports, and other associated scientific technical documents.
  • Perform testing of study samples to support upstream and downstream manufacturing process development, characterization, and process improvements.
  • Document and evaluate experimental results and perform data verification and trending.
  • Provide technical expertise and guidance to support investigations and help troubleshoot analytical operational issues.
  • Identify new analytical technologies and opportunities for technical advancements.
  • Support the preparation and review of regulatory submissions related to analytical procedures, method development and validation, specifications, reference standards, extended characterization, and product stability / shelf-life.
  • Support regulatory inspections, third-party audits, and customer audits through participating in inspection readiness and addressing inspectional findings.
  • Perform routine laboratory activities including sample management, instrument maintenance and calibration, inventory and ordering of supplies, general housekeeping, and other related activities.
  • Work in a diverse group environment while focusing on inclusivity and safety to produce high quality, compliant results.

Quals

Education / Experience / Licenses / Certifications :

  • B.Sc. / B.Eng. or M.Sc. / M.Eng. in Biology, Chemistry, Biotechnology, or equivalent area of related study with 0-5 years industry experience in biologic / protein analytics.
  • Experience across the analytical method lifecycle in protein biotherapeutics for a variety of methodologies and instrumentation used in the testing and characterization of raw materials, excipients, in-process, drug substance, and drug product samples including HPLC / UPLC methods and various other analytical techniques (i.e., qPCR, ELISA, CE-SDS, iCIEF, SDS-PAGE, UV-VIS, western blotting, mass spectrometry, and cell-based assays) is preferred.
  • Working knowledge and experience in the biopharmaceutical development process, GMP, PAT, CMC and regulatory guidance, ICH guidelines, and compendial requirements is desired.
  • Experience authoring, validating, and coordinating timely transfer of test methods with and to Quality Control laboratories is desired.
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