My client is expanding and seeks a Sr Manager to oversee analytical development for small molecule therapeutics. The ideal candidate will take on the following tasks:
- Direct daily activities of CROs and oversee the characterization efforts, method optimization, validation, and transfer activities, and stability study management for APIs and drug products
- Manage the characterization of product and impurities and determine degradation pathways.
- Collaborate with QC, manufacturing, QA, and regulatory counterparts to develop protocols and reports for API and DP, including trending analysis, etc.
- Prepare and review of relevant CMC sections in support of regulatory submissions.
- Oversee stability programs, including review of stability protocols, reports and data, data management and trending
- Support batch record review and QC data, including trending
The ideal candidate will possess the following qualities:
- Scientific degree and extensive analytical experience, including working with small molecules
- Experience with Mass Spectroscopy desired
- Previous management of CROs
- Experience setting specifications based upon statistical analysis and reviewing deviations, OOS, OOT, and change controls
- Excellent technical writing skills and editing of technical reports, including CMC regulatory filings
- Thorough knowledge of GMPs, ICH, USP, EP