Senior Manager, Analytical Development & QC

6+ years of relevant industrial experience in analytical development/QC.

Solid understanding of relevant compliance and regulatory requirements as applicable to data integrity, QbD, process validation, manufacture sampling and testing, stability study, method validation and transfer, etc.

Extensive knowledge and understanding of cGMP guidelines and practices, as well as related / best industry practices.

Experience in solid oral dosage including dissolution testing.

Commercial QC experience is preferred.

Chromatographic experience in development, optimization, and troubleshooting.

Playing a leading role and Subject Matter Expert (SME) of Quality Control within PDM Analytical Development & QC department in support of RevMed clinical and commercial programs, the position will be mainly responsible for managing QC activities from process validation to commercial manufacture of drug substance (DS), drug product (DP) and final product (FP), including managing stability programs, reference materials, and raw materials at contract organization.

Provide support for stability program management, quality systems and QC documentation (e.g.

SOPs) and PAI readiness and inspection as needed.

Coordinate and manage outsourced QC activities of late phase to commercial programs at CDMOs and / or contract testing labs (CTLs), including but not limited to in-process control test, final release test, and stability study.

Manage quality events related to QC testing such as lab investigation (e.g., OOS/OOT), deviations, change controls (e.g., CBE 30/CBE 0) and CAPAs.

Lead method validation/transfer activities at CDMOs and / or contract testing labs (CTLs)