Lauren Mermelstein
Coatesville
Summary
Experienced and dedicated Quality professional with over 12 years of combined experience within the pharmaceutical and biotech industry. Proven experience in quality oversight of manufacturing activities, tech transfer processes, and batch release within cell and gene therapy manufacturing. Highly detail oriented and adept in making quality decisions to ensure the manufacture of safe, high quality, and efficacious product.
Overview
13
13
years of professional experience
Work History
Group Leader Quality Assurance
Teva Pharmaceuticals
06.2023 - Current
- Lead trainer or SME on specific responsibilities within the QA Product Disposition team (i.e. product disposition or QA on-the-floor)
- Lead for disposition of cell bank (CB), bulk drug substance (BDS), and drug product (DP) and approval of supporting documentation to ensure for continuity of clinical trial activities
- Lead reviewer and approver of CB, DS, and DP master batch records related to product introduction and re-introduction
- Lead reviewer and approver of executed product (CB, BDS, and DP) and media/buffer batch records
- Lead QA for start of batch activities for lot number assignment in SAP and batch record issuance
- Lead reviewer and approver of CB, BDS, and DP campaign summary reports in support of IND and BLA enablement
- Ensure timely review and approval of change controls, deviations, investigations, CAPAs and CAPA Effectiveness checks using site QMS
- Lead development and review of CAPA action plans, facilitating CAPA completion as well as ensuring appropriate effectiveness checks
- QA lead for review and approval of SOPs, Work Instructions, and controlled forms
- QA lead for archival of batch record documentation following product disposition
- Ensure MFG activities and their associated documentation are performed/completed using current Good Manufacturing Practices
- Support regulatory agency filings, inspections, and internal audits, as needed
- Lead/assist in development and/or delivering training programs, and administration as required
- Use of SAP, Trackwise, TevaDoc, LIMS, and TevaLMS to execute GMP QA activities as applicable
- Back-up for QA support and oversight of media fills
- Back-up for QA On-the-floor support during critical manufacturing activities
- Back-up QA lead for internal technology transfer teams for new product introduction and re-introduction
- Back-up for QA On-the-floor support during critical manufacturing activities
Quality Analyst III
Teva Pharmaceuticals
04.2022 - 06.2023
- Review and approval of Technical Transfer Reports (TTR) for Cell Bank (CB), Bulk Drug Substance (BDS), and Drug Product (DP) for transfer of manufacturing processes from Process Development to the Biologics Manufacturing Facility in support of new product introduction and re-introduction
- Provide Quality Assurance oversight during technology transfer team meetings
- Review and approval of automation recipes in support of product introduction
- Review and approval of CB, BDS, and DP master batch records in alignment with the technology transfer report (TTR)
- Review and approval of executed batch records including CB, BDS, DP, and media/buffer
- Review and approval of analytical test results for final release testing of CB, BDS, and DP and associated CoA in support of product disposition.
- Review and approval of deviations, OOS/OOT investigations, change controls and CAPAs
- Completion of Product Disposition activities for cell CB, BDS and DP within SAP.
- QA oversight of media fills and review and approval of media fill summary reports
- Review and approval of documentation for product changeover and equipment changeover
- Authorship, revisions, review and approval of site SOPs, Work Instructions and Forms as needed.
- Support site efforts to ensure compliance with Teva Policies and Standards, and regulatory requirements and GMP guidelines.
Scientist, Quality Assurance
Puresyn Inc
11.2016 - 04.2022
- Maintain proper documentation related to Quality Assurance (QA)
- Lead for employee training for new QA team members
- Perform SOP and Controlled Document development, editing, review and approval
- Executed batch record review and approval
- Compiling and reviewing manufacturing summary reports
- Perform monthly and quarterly Quality Audits, document any and all observations, and ensure implementation of appropriate remedial action with CAPA (as required)
- Management of TSE/BSE statements for raw materials and consumables
- Management of the Approved Supplier List
- Issuance, review, and approval of contract documentation, QC final release and in-process test data and associated documentation
- Review and approval of various production, facilities, and QC lab daily forms for monitoring of systems and equipment
- Review and approval of equipment qualification documentation.
- Review and approval of equipment work orders, calibration, and PM documentation and equipment tags
- Management of approved vendor performance
- Completion, review, and approval of MFG process change controls
- Review and approval of employee OPS training and management and oversight of employee training program
- Author project reports for vendor on-boarding
- Provide QA oversight of MFG deviations
- Lead Corrective and Preventative Actions (CAPAs) and assess effectiveness
- Release and reconciliation of dedicated materials and consumables for manufacturing use
- QA oversight of plasmid shipments
- Participate, as needed, in customer audits and inspections
- Serve as a member of the safety committee as required.
QA Principal Investigator
Fibrocell Sciences
06.2015 - 06.2016
- Document all non-conformance events and conduct Manufacturing Investigation Reports (MIRs) and deviations (DEVs) thoroughly to identify all impact to patient, product quality, and regulatory compliance in order to support day-to-day clinical and commercial operations.
- Complete accurate and thorough root cause analysis to identify all contributing and potentially contributing factors which led to the non-conformance.
- Identify and develop meaningful and effective Corrective and Preventative Actions (CAPAs) with regard to improvement in quality systems, processes, and product in accordance with all regulatory requirements.
Quality Control Biotechnician
DSM Biomedical
08.2014 - 06.2015
- Lead for all LAL testing (kinetic turbidimetric and gel clot) for the detection of Gram-negative bacterial endotoxin in all in-process and final products.
- Ensure measured endotoxin levels conform to pre-determined specifications in order to meet product safety standards.
- Monitor manufacturing facilities by conducting weekly viable and non-viable air and surface environmental monitoring as well as weekly bioburden testing of the WFI system.
Microbiologist
West Ward Pharmaceuticals
11.2013 - 07.2014
- Conduct daily viable and non-viable environmental monitoring (EM) in controlled primary and secondary production facilities using aseptic technique.
- Perform read and review of environmental monitoring test plates on a daily basis for microbial growth.
- Ensure any and all microbial growth is documented and submitted for identification.
- Initiate and author Laboratory Events (LEs) and Laboratory Investigations Reports (LIRs) for microbial growth that exceeds documented ISO standards.
- Assist in observation of aseptic technique during all Media Fill Trials.
- Observe all manufacturing personnel in production facilities for use of proper aseptic technique.
QC Technician
Rockland Immunochemicals
05.2012 - 06.2013
- Achieve accurate and precise high-through put IEP testing of polyclonal/monoclonal primary and secondary antibodies, IgG fractions, conjugated, and affinity purified antibody products ranging in host and target species.
- Utilize SDS-page testing in high throughput to assess host purity and identity of different antibody and identity of different antibody fragments (i.e. IgG, IgA, IgM, Fab, Fab2, Fc) and other non-antibody molecules.
- Employ Western Blotting to test for antibody target reactivity of a varied range of primary and secondary antibodies.
- Test weekly production bleeds, ensuring only high titer serum is used for production.
- Maintain accurate injection boost records of production animals with regard to USDA standards.
Education
Bachelor of Science - Biology, French Language
Ursinus College
Collegeville, PA05-2012
Skills
- Effective Communication
- Critical Thinking
- Attention to Detail
- Root Cause Analysis
- Deviation Management
- GxP Compliance/Data Integrity
- Inspections/Audits (Scribe, Back Room)
- SAP
- Trackwise
Timeline
Group Leader Quality Assurance
Teva Pharmaceuticals
06.2023 - Current
Quality Analyst III
Teva Pharmaceuticals
04.2022 - 06.2023
Scientist, Quality Assurance
Puresyn Inc
11.2016 - 04.2022
QA Principal Investigator
Fibrocell Sciences
06.2015 - 06.2016
Quality Control Biotechnician
DSM Biomedical
08.2014 - 06.2015
Microbiologist
West Ward Pharmaceuticals
11.2013 - 07.2014
QC Technician
Rockland Immunochemicals
05.2012 - 06.2013
Bachelor of Science - Biology, French Language
Ursinus College
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