Anthony Mahan Email & Phone Number

New York, New York, Us

- GMP/GCP Vendor Oversight- Managing pool of nonGMP, GMP and GCP vendors- Author, maintain and amend quality assurance agreements- Perform vendor audits (GMP and GCP) against regulatory and business requirements- Liaise with vendor Quality Assurance to manage relationships- Manage enhanced oversight plans of high-risk vendors- Track, remediate and report quality issues involving vendors- Initiate and participate in continuous improvement efforts in Quality Assurance

New York, New York, Us

Formulations- designed and conducted preformulation characterization for non-conventional formulation strategies for poorly soluble substrate- Develop analytical methods to assess physicochemical parameters (stability, solubility, etc.) of small molecules (HPLC, Spec, TGA, DSC, DLS) - Advanced predictive computational approaches/methods to identify critical physiological and physiochemical factors affecting oral absorption- Utilized in silico modeling tools to advance molecular candidate formulations - Successfully participated as a departmental representative on interdisciplinary project teams- Led internal team on biorelevant permeability - Designed and implemented lab work flow to improve efficiency and outputGCP Assessor (pharmacy)- Lead and manage the cross-functional external contract research unit pharmacy assessment program- Plan and conduct assessments of processes and programs at contract research unit/investigator study sites in accordance with internal and regulatory (USP, ICH, CFR) requirements- Author, review and distribute audit reports and corrective actions - Manage post-assessment activities and follow-up on any necessary site-specific corrective and preventative actions

New York, New York, Us

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