PAULINE HUOTH
Tyngsboro,MA
Summary
Highly motivated professional with over 15 years of biopharma industry experience, demonstrating results-oriented strategies in diverse GMP manufacturing settings, including established commercial organizations, Phase III clinical trial start-ups, contract development manufacturing organizations, and early-stage start-ups preparing for operational readiness.
Overview
16
16
years of professional experience
Work History
Quality Assurance Manager
CRISPR Therapeutics Framingham
Framingham
07.2023 - Current
- Manages deviation investigation activities related to GxP manufacturing and testing.
- Collaborating with cross-functional teams to ensure the appropriate risk assessments are conducted prior to approving process changes.
- Release of GxP Raw materials and Product Lot Disposition
- Review and approve; Deviations, Corrective and Preventative Actions (CAPAs), Change Controls, Effectiveness Checks Laboratory Investigations and RBIAs (Risk Based Impact Assessments)
- Serving as a QA subject matter expert on process improvement initiatives to reduce deviations.
- Review and Approve site-wide Operational SOPs and documentation such as MBRs, material specification, product specifications.
- Performing gap analyses on processes, systems, and practices and recommending and implementing corrective actions and improvements.
- Ensuring CRISPR's QMS records are maintained in a state of inspection readiness.
- Participating in internal QP audits and regulatory inspections.
- Gathering, preparing, and reporting relevant Quality Metrics using Veeva.
- Collaborating with key internal partners including Quality, Manufacturing, Facilities, Quality Control, and Supply Chain.
Manufacturing Manager
CRISPR Therapeutics Framingham
Framingham
01.2022 - 07.2023
- Led and collaborated+ manufacturing facility start-up activities with accountable milestones including EMPQ execution, material program establishment, supporting documentation, tech transfer, recruitment, training of manufacturing team and successfully executing Operator Aseptic Qualifications, Aseptic Process Validation and GMP Drug Product runs.
- Used risk management, investigative techniques, root cause analysis and quality concepts in the identification and evaluation of any potential risks during manufacturing.
- Collaborated with PD, MSAT and QA to successfully tech transfer Immuno-oncology (CTX112, CTX131 and CAR-T-Cell Isolation) pipeline for GMP readiness.
- Ensured all materials and equipment are identified and available in time for manufacturing activities.
- Scheduled activities and drove department initiatives
- Led and mentored a team of (9) manufacturing associates.
- Reviewed and approved of executed Manufacturing document and records.
- Trained employees on aseptic manipulations within an ISO grade 5 environment (BSC and RABs)
- Authored and generated aseptic process simulation batch record and aseptic operator validation.
- Authored and generated processing batch records for CTX112 and T-Cell Isolation.
- Collaborated with Quality Assurance, Manufacturing Science & Technology, Quality Control and supply chain to find alternatives of bill of materials due to supply chain issues and to ensure successful delivery of drug products.
- Prioritized, initiated, reviewed and approved manufacturing continuous improvement initiatives including SOP revisions.
- Ensured cGMP compliance through consistent execution.
- Initiated, Investigate and documents minor/ major deviations, CAPAs and change controls.
- Performed periodic CAPA effectiveness reviews.
- Actively undertook all pivoted projects to support manufacturing site development.
- Development of CTX112: A Next Generation Allogeneic Multiplexed CRISPR-edited CAR T Cell Therapy with Disruptions of the TGFBR2 and Regnase-1 Genes for Improved Manufacturing and Potency
Manufacturing Supervisor
CRISPR Therapeutics
02.2020 - 01.2022
- Collaborated with multiple CDMO and internal stakeholders to understand planned changes and manage the end-to-end implementation of agreed changes including change controls and impact assessments supporting CTX001 (Exa-cel).
- Person in Plant both national and international CMOs-provided operational oversight of, and troubleshooting support to, CDMOs to ensure all deliverable.
- Identified and escalated business-critical issues to Commercial Manufacturing and Supply Chain and Quality leadership
- Batch Record Creation and onboarding of Bill of Materials
- Review and approved of executed Manufacturing document and records.
- Ensured all materials and equipment are identified and available in time for manufacturing activities.
- Performed gap assessments between multiple CMOs to ensure business requirements are met.
- Maintained strategic relationships within the CDMO organization.
- Manage and tracked batch record data in appropriately compliant systems to support BLA filing submissions.
- Review and approved of executed Manufacturing document and records.
Drug Product Supervisor
BrammerBio part of Thermofisher Scientific
02.2019 - 02.2020
- An experienced viral vector CDMO supporting gene therapies and is focused on process and analytical development, clinical and commercial supply.
- Managed daily tasks for Drug product/ Fill Finish team.
- Supported Factory Acceptance Test for the Bausch and Stroebel filler (Ilshofen, Germany)
- Supported Satisfactory Acceptance Test for the Belimed Autoclave, Bausch and Strobel filler and SKAN isolator.
- Authored cleanroom gowning procedure to meet cleanroom specification requirements (Grade A, C, D)
- Authored Aseptic Process Simulation work instruction and batch record to evaluate the sterility confidence of the drug product filtration and fill finish processes.
- Review and approved commissioning test protocols.
Manufacturing Supervisor
Histogenics Corporation
03.2014 - 02.2019
- A regenerative medicine company focusing on the autologous treatment of focal chondral defects with its' unique tissue manufacturing process and platform utilizing a combination of cell culture, biomaterials (scaffolds and adhesives) and a proprietary bioreactor.
- Managed and scheduled daily tasks for manufacturing personnel.
- Oversaw and executed formal Process Development studies intended to support the BLA filing and a Japanese Clinical trial.
- Reviewed GMP related documents for GMP compliance.
- Ensure adherence to professional lab standards and practices to maximize safety and operational effectiveness.
- Executed equipment IQ OQ PQ
- Authored CAPA, Change controls, IQ, OQ and PQ, Document Change Orders, Deviations
- Provided guidance to manufacturing associates on documentation generation (DEV, CAPA, DCO, OOT, OOS)
- Point of contact for troubleshooting with the proprietary bioreactor
Senior Manufacturing Associate
Genzyme Biosurgery, Carticei
03.2011 - 03.2014
Education
Biological Science - Biotechnology
University of Massachusetts Lowell
01-2010
Skills
- Investigation of deviations and risk assessments
- Management of CAPA and GxP compliance
- Improvements in processes and change control
- Mitigation of risks through analysis
- Quality management systems with regulatory adherence
- Operations in manufacturing with continuous enhancements
- Transfer of technology with batch record oversight
- Leadership in teams with corrective action strategies
Timeline
Quality Assurance Manager
CRISPR Therapeutics Framingham
07.2023 - Current
Manufacturing Manager
CRISPR Therapeutics Framingham
01.2022 - 07.2023
Manufacturing Supervisor
CRISPR Therapeutics
02.2020 - 01.2022
Drug Product Supervisor
BrammerBio part of Thermofisher Scientific
02.2019 - 02.2020
Manufacturing Supervisor
Histogenics Corporation
03.2014 - 02.2019
Senior Manufacturing Associate
Genzyme Biosurgery, Carticei
03.2011 - 03.2014
Biological Science - Biotechnology
University of Massachusetts Lowell