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Urgent! Bio-Analytical Scientist Job Opening In East Syracuse – Now Hiring Artech LLC

Bio Analytical Scientist



Job description

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.

 


Required Skill Profession

Life Scientists



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