-Analytical Lead for late phase/commercial biological drug products. -Responsible to ensure timely method validation, analytical technology transfer, and compliance.-Support/Own Deviations, Investigations, Change Controls, and Audits.-Review/Approve/Author CMC sections of regulatory submissions, CoAs, Specifications-Interact with CMOs and CROs to support projects.

-Manage project deliverables and milestones, including personnel and resource allocations.-Track project scope, budgets, and timelines.-Coordinate project team meetings (scheduling, agenda, material, minutes).-Act as point of contact for clients and team members across multiple projects. -Assist with Trial Master File for clinical studies.

-Performed GLP/GMP testing for release, stability, cleaning and toxicology samples. Report and/or investigate any data Out of Trend, Out of Specification or outside of acceptance criteria.-Performed HPLC method development and validation.-Authored, reviewed GLP/GMP technical documentation (raw data, analytical methods, experimental plans, validation protocols and reports, SOP's, Work Instructions, IND submissions, COA's).-Coordinated the analytical phase of GLP studies, including serving as Principal Investigator, performing method development and validation, protocol review, participation in audits, receive/log in samples, issue study monitor notifications, author analytical data statements, perform stability studies, prepare facility for Quality inspections/audits.-Served as a department SME in GLP regulations by providing training and writing/updating/reviewing SOP's, methods and work instructions.-Served as the department representative for contract labs.-Served as a department lead for DEA compliance of controlled substances. Handled CII - CIV scheduled materials including issue of DEA 222 forms.Analytical techniques:-Small molecules - HPLC, UPLC, Karl Fischer, Infrared Spectroscopy, Dissolution, Disintegration, Friability, Hardness/Thickness, pH, appearance, Particle Size Analysis.-Large molecules - Visual Examination, UV, pH, SDS-PAGE, cIEF.Software:-Waters Empower, Agilent Chemstation, Microsoft Office, LabWare LIMS, Trackwise, ComplianceWire, QDocs, and SAGE.Administrative:-Supervised up to three chemists.-Managed training for New Employee Orientation.-Maintained the general organization of the laboratory. Managed month lab task assignments for group.-Trained to use VBSE hoods, biosafety hoods and PAPR.-Received and discarded samples.-Participated in the interview process for new employees.-Experienced in interacting with vendors and selecting new laboratory equipment.-Participated as a member of the Emergency Response Team.