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Develop simple and complex physio-chemical methods, overseeing compendial verifications, and performing GMP testing and validation activities. Introduce new technologies and collaborate with the AD & QC team to develop new ways of working to enable rapid progression of various gene therapy candidates into the clinic. Specifically:

Develop, qualify, and transfer analytical methods to support drug substance and drug product GMP release and stability testing.
Evaluate and implement new technologies within the Analytical Development Department, with an emphasis on state-of-the-art separation techniques (HPLC/UPLC and CE) and binding based assays.
Work in a GMP-compliant laboratory environment and ensure departmental SOPs, internal Sanofi standards and applicable regulations are consistently followed.
Write and review method protocols, assay qualification and validation plans and reports and ensure that documents adhere to GxP requirements and ICH guidelines.
Troubleshoot existing protocols to increase method performance, throughput, and ergonomic control.
Write analytical sections of IND/IMPD filings.
Represent analytical development in cross functional meetings for projects and analytical initiatives.
Lead internal and external assay transfers consistent with established Sanofi procedures.
May provide technical oversight and manage the workload for a few junior analysts

Work remotely from residence 2-3 days a week so long as that is within normal commuting distance or within the same metropolitan statistical area.

Please copy and paste your resume in the email body do not send attachments, we cannot open them and email them at candidates at (link removed) with reference #585156 in the subject line.