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Solution-focused Technical Operations and Quality professional with 20 years of experience in clinical and commercial pharmaceutical/biotech industry and 13 years in leadership roles. Proven track record of successfully leading teams through CMC development and product commercialization, including FDA approval for Provenge® and Phexxi®. Extensive knowledge of GMP pharmaceutical DS and DP manufacturing of diverse dosage forms including oral and parenteral for clinical and commercial use. Dynamic leader and motivator using an effective combination of analytical and interpersonal skills. Excels in CMC strategic planning, team leadership, and continuous process improvement in all areas of operations. Key competencies include:• GMP Facility Design & Start-Up• CMO/ CPO/ CLO Management• Drug Substance and Drug Product, Cell Culture and Combination Product Manufacturing• Global Strategy Development and Implementation• IND, IMPD, BLA, NDA/ CMC Writing• Regulatory Compliance and Inspections • Quality System Remediation• Process Improvement and COGs Optimization• Validation Subject Matter Expert (Facility/ Utility/ Equipment Commissioning & Qualification, CSV, Process/ Cleaning/ Sterilization/ Shipping/Analytical Method Validation, Media Fill) • Investigations, Root Cause Analysis & CAPA Implementation• Aseptic Processing• Project & Staff Management
Mileka Llc
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Mileka LlcSan Diego, Ca, Us
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Vice President Technical OperationsEvofem Biosciences Jul 2020 - Sep 2024San Diego, Ca, UsHead of Technical Operations including Manufacturing, Supply Chain/Logistics, Engineering, Validation, Product Development, Project Management, Technology Transfer, Process Improvements and Quality. Developed and implemented forward-looking CMC strategies for the development and commercialization of products, leading to FDA approval for Phexxi® (combination drug product). Oversaw the planning, execution and management of manufacturing operations performed at CMO/CPOs/CLOs and other critical suppliers involved in the manufacturing, packaging, testing, distribution of commercial and clinical products. -
Associate Vice President Technical OperationsEvofem Biosciences Oct 2019 - Jun 2020San Diego, Ca, Us
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Independent ConsultantMileka Consulting Group Nov 2018 - Oct 2019Deliver experienced strategic business and technical consulting services with a focus on biotech/pharma manufacturing process operation and improvement, cell therapy manufacturing facility design/validation/regulatory inspection and start-up, CMO evaluation/audit/oversight, IND/BLA CMC document writing, GMP MFG facility/equipment/system validation, process characterization and process validation, aseptic processing, regulatory compliance and inspections, MFG/Eng. investigations/root cause analysis/CAPA implementation, supply chain management, critical raw material supplier evaluation/audits/qualification, SOP development and implementation, quality system remediation.
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Sr Director Technical OperationsVital Therapies, Inc. Jun 2018 - Sep 2018Head of Engineering, Facilities and Validation at the cell cartridge manufacturing facility. Developed and managed site Validation Master Plan, Facilities & Engineering, Validation programs. Led, developed and managed BLA (CMC section) and PAI activities, schedules and timelines. Hired, managed, trained and mentored a team of 12 FTEs (Directors, Managers, Supervisor and Engineers) and consultants. Represented Engineering, Facilities and Validation during regulatory inspections.
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Director Technical OperationsVital Therapies, Inc. Jul 2014 - May 2018• Headed, designed and managed new commercial GMP MFG facility project within timeline and budget (100k sq.ft. facility, $60M, full redundancy design, compliant to EU & US regulations). Successfully completed the facility design phase and site selection• Upgraded San Diego MFG facility design to improve compliance. Purchased, start-up of new equipment/systems and revalidated entire facility, utilities and equipment in preparation for QP audits, BLA filing and site PAI within a year timeline ($3.5M CAPEX project)• Created Process Development group (hired 1 Director and 1 Manager), set performance goals and responsibilities• Developed and oversaw process characterization effort in collaboration with MFG, R&D, RA and QA groups. Developed process FMEA and identified process CQAs and CPPs needed for Process Validation (PPQ), BLA filing and commercialization. Authored IND CMC documents to support regulatory filings and FDA meetings• Oversaw process improvement projects by implementing and validating an automated cell factory manipulator, single use disposable material and supported the design of a more efficient and compliant bioreactor• Managed facility/ equipment/ process investigations, troubleshooting, root cause analysis, and corrective action implementation in collaboration with MFG, R&D, PD, RA and QA• Directed and facilitated Raw Material Task Force (cross functional team). Evaluated critical material supply chain process (identified critical raw material, supplier qualification/audits, in-coming and IPC testing), identified gaps and implemented action items• Developed and implemented aseptic process validation program (media fill) at MFG facility• Developed and managed Technical Operation’s department budgets ($5M - $8M/ year)
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Critical Equipment Validation ManagerSandoz (Novartis) Feb 2013 - Jun 2014Managed site’s Validation program and activities under a remediation environment (FDA warning letter received before I joined the company). Restructured and improved Sandoz Validation program and executed validation remediation activities leading to full FDA warning letter recovery. Hired, coached, trained and supervised a team of 7 Validation Engineers and directed a team of up to 15 consultants.
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Validation ManagerDendreon Corporation Jul 2010 - Oct 2012Seal Beach , Ca, UsDeveloped, implemented and managed the Engineering Commissioning, Qualification and Validation programs for 2 new Immunotherapy Manufacturing Facility start-ups in New-Jersey and California. Successfully completed FDA PAI inspections leading to both facilities FDA approval. (Facilities were later acquired by Novartis and Valeant Pharmaceuticals). Hired, trained and led a team of 5 Validation Engineers and directed a group of up to 20 Validation consultants at both MFG facilities. -
Validation SupervisorDendreon Corporation Jul 2009 - Jul 2010Seal Beach , Ca, Us
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Sr Validation EngineerDendreon Corporation Jan 2007 - Jul 2009Seal Beach , Ca, UsDeveloped and led Validation / Calibration activities at the Seattle WA and Morris Plains NJ facilities.
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Process EngineerRatiopharm May 2005 - Sep 2006Ulm, Baden-Württemberg, DeInvestigated, troubleshoot and improved solid dose/ liquid manufacturing, aseptic fill/finish and packaging processes. Reported directly to the Plant Manager. Purchased equipment, managed start-up activities with cross functional teams.
Katherine Mercier Skills
Katherine Mercier Education Details
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Université De SherbrookeB.S. Chemical Engineering
Frequently Asked Questions about Katherine Mercier
What company does Katherine Mercier work for?
Katherine Mercier works for Mileka Llc
What is Katherine Mercier's role at the current company?
Katherine Mercier's current role is Vice President Technical Operations.
What is Katherine Mercier's email address?
Katherine Mercier's email address is km****@****eon.com
What is Katherine Mercier's direct phone number?
Katherine Mercier's direct phone number is +185875*****
What schools did Katherine Mercier attend?
Katherine Mercier attended Université De Sherbrooke.
What skills is Katherine Mercier known for?
Katherine Mercier has skills like Project Management, Validation, Process Improvement, Gmp, V&v, Cross Functional Team Leadership, Pharmaceutical Industry, Manufacturing, Quality Control, 21 Cfr Part 11, Quality Assurance, Change Control.
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