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Senior Manager, Small Molecule Analytical Development

Posted on Nov 5, 2020 by Job Juncture

Philadelphia, PA 19019
Customer Service
Immediate Start
Annual Salary
Full-Time

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

Reference: 995144560

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