Project Leader on data integrity assessment, resolution and implementation for the site. Led large project team for suite enhancement to allow processing of high titer CHO products. Led multiple project teams for start-ups and introduction of new equipment to support the manufacturing of process validation and commercial campaigns, including FATs, planning for manufacturing campaigns, and creation of all documentation (material specification, Batch Records and SOPs). Collaborated with various cross-functional work teams to streamline and improve processes, resulting in reduced cost, processing time, and Non-Conformance Events (NCEs). Serve as a co-host of inspectors during inspections from various regulatory agencies.

Oversaw the quality assurance unit supporting manufacturing operations. Managed a team of six quality assurance specialists whose primary focus was ensuring Inoculum, Cell Culture, Purification and Bioservice operations were executing with high quality standards. Review and approved deviations, change controls, quality agreements and quality plans required for day to day manufacturing.

Manage and implement various continuous improvement projects for manufacturingPerform facility fit and feasibility for various molecules in pipelineAuthor and Investigate Cell Culture process related Non-Conformance Events

Effectively manage the Process Validation Campaign for LA300a and IMC – 1121B, provide updates to Senior ManagementImplement and adapt product transfers from Lilly & ImClone PD Author and Investigate Non-Conformance Events (NCEs) utilizing Root Cause and KT analysisRepresent MFG in Raw Material planning and NCE review weekly meetingsCollaborate with Procurement to order new raw materials for all campaignsCoordinate all Calibration and PM activities with Metrology and FacilitiesKey member of project team to streamline Sample Coordination using Six SigmaManaged all start-up activities for Suite2 purification suiteReview and approve validation protocols for IQ/OQ/PQs Plan and implement the validation schedule with VTS and Engineering Review and supply technical insight to regulatory/Man Tech for BLA and CBE-30 filings Successfully manage the manufacturing side of the 600K budget for start-upPerform FATs on 1.4m chromatography columns and skidsParticipate in FDA, EU and Health Canada audits with no 483sContinue to develop junior supervisors and operators in suite 2, implementing one on one meetingsCreate a campaign planning spreadsheet to optimize timelines and coordination of activities for running multiple products Meet with AEG and Engineering to help develop the Historian Corporate-side for purificationSupervise the revision of purification job plans with the support of facilities and engineeringParticipate in process optimization implementation (TFF, Bulk Fill) to increase product yields and qualityWork collaboratively with cross-disciplinary project teams (QA, QC, PD, Facilities, Engineering, Manufacturing Technology and Validation) for Suite1 and Suite2Interview and recommend hiring personnel to senior management and HR

Supervise all purification production for second shift Coordinate all support functions with purification on second shift Plan the master production schedule for all purification activitiesOversee all training and developmental growth of my direct reportsParticipate in FDA audits, successful PAI for BB50 resulted in no observationsMember of the Tech Transfer TeamParticipate in Harmonization meetings for Manufacturing

Senior OperatorLead troubleshooting activitiesReview and approve batch records and SOPs for processing Perform IQ/OQ/PQs on all the systems in the purification suites Interview and train new operators / supervisors on the equipment used in the commercial facilityMeet with vendors; obtain quotes and order equipment / suppliesOperator IIIPerform IQ/OQ/PQs on all the systems in the purification suitesCreate recipes for chromatography and TFF skids using Millipore CCP5 softwareOriginate and revise Manufacturing Records and Standard Operating Procedures

Lead third shift production activities in purification: chromatography, ultra-filtration, and spectrophotometryOriginate and revise Manufacturing Records and Standard Operating ProceduresComplete and review batch records in accordance with cGMPsCreate recipes for chromatography and TFF skids using Unicorn softwarePerform IQ/OQ/PQs for the start up of a Phase III facility (Redmill)