Analytical Development - Manager / Sr. Manager

The Senior Manager of Analytical Development will join the Analytical Development Team within Chemistry and Manufacturing and Controls (CMC) and report to a Director of Analytical Development.

This role will work closely with the entire CMC team to execute late-stage development activities in support of Phase III clinical trials through commercial activities.

At least 7 years of experience in analytical development in a pharmaceutical setting

Proven leadership experience in managing analytical chemists at various levels externally (CMO mgmt.)

Independently proficient in a variety of analytical techniques and regulatory areas including, but not limited to HPLC, LC/MS, GC, GC/MS, USP dissolution testing apparatus, pH meters, UV/Vis spectroscopy, KF, and phase appropriate analytical method validation

Knowledge and direct experience with CMC analytical regulatory requirements and authoring of IND/IMPD filings and response to regulatory inquiries; experience applying regulatory guidelines (ICH, FDA, EMA, etc.) to pharmaceutical development and CMC strategy

Oversee contract development and manufacturing organizations (CDMOs) to manage analytical development and quality control (QC) activities for drug substance (DS) and product (DP)

Manage analytical documentation (i.e., CofAs, test methods, protocols, reports, specifications, stability, and raw data) within Quality Management System (QMS)

Support and author analytical content for CMC Regulatory content for U.S.

and Rest of World dossiers

Manage GMP stability studies and provide trend analysis in support of retest and shelf-life extension

Manage reference standard program (i.e., qualification, storage, inventory, distribution)