Neti Hansen
Redwood City,CA
Summary
Accomplished professional with over 18 years in small molecule, biologics, and generic drug product development. Expertise includes authoring SOPs, executing study protocols, and managing CAPA and QC stability studies. Subject matter expert in cleaning validation with extensive knowledge of FDA, ICH, and global quality systems regulations. Proven experience in inspection response guidance and CAPA remediation.
Overview
28
28
years of professional experience
Work History
GMP Compliance Expert
Genentech
04.2015 - Current
- Responsible to ensure Roche Global Quality standards for Cleaning validation and reagent handling meets Health Authority (HA) standards. Maintained compliance with HA standards.
- Network Quality lead for Cleaning validation network. Led implementation strategy for global documents, process optimization, and multi-site CAPA.
- Author of health authority regulatory dossiers filing. Successfully implemented protein inactivation for cleaning at the DS sites, helped teams finalize studies, summarize reports, and participated in filing of Bio DS multi-product eCP. Worked with PTR colleagues complete multi-site change and provide HA updates to Health Canada, EU, FDA, and Countries A, and B.
- Guided clinical workstreams since 2015, enabling flexibility in implementing Global PQS standards for IMP teams to achieve the 1000 days goal.
- Directed the standardization of cleaning validation approaches. Leading the Drug Product optimization (both small molecules and biologics) to standardize validation, revalidation, monitoring, and periodic review approaches to provide cost savings, easier tech transfers, and reduce equipment downtime.
- Directed the update of quality standards to comply with EU Medical Device Regulation.
- Facilitated Kaizen initiatives to drive continuous improvement and engage team members. and certified in Lean Methodology.
- Directed development of Global Network Quality Standards to align with regulatory requirements. and Recognized SME
Sr Validation Engineer
Impax Laboratories
09.2013 - 03.2015
- Resolved observations from Parexel and Tunnell Audit by drafting project plan and leading team to address Quality Systems issues.
- Successfully resolved observations from Parexel, and Tunnell Audit by drafting the project plan and leading team to resolve the Quality Systems.
- Revised and Authored the Cleaning Validation Master Plan for Hayward site. In order to align the programs reviewed/approved the Cleaning Validation Master plan for the packaging site.
- Recalculated Maximum Allowable Carryover limits based on risk-based approach and led the analytical and Quality Assurance team to revalidate the cleaning agents, and API residue detection methods.
- Successfully completed cleaning validation of the worst-case products. Manage the routine monitoring program and introduction of new products to commercial operations.
- Provide cleaning validation program overview and served as subject matter expertise in the 7 week FDA inspection. Participated and served on the team made up of Directors, Sr. Directors, and Vice President to respond to 483 observations.
- Group Lead for the Cleaning Validation Program for Commercial Manufacturing Operations
- Provided cleaning validation program overview and served as subject matter expert during 7-week FDA inspection, collaborating with team of Directors, Sr. Directors, and Vice President to respond to 483 observations.
- Serve as technical expertise to both internal and external sites to align the cleaning best practices.
Associate Scientist
AstraZeneca
08.2001 - 09.2012
- Worked on a variety of vaccine programs ranging from Pre-candidate to drug (CD) nomination, Phase 1, Phase 2, Phase 3, and post market studies for FluMist (Trivalent Live attenuated Influenza Virus (LAV), Respiratory Syncytial Virus (RSV), Para Influenza Virus (PIV), Cytomegalovirus (CMV), and Epstein Barr Virus (EBV) candidate vaccines.
- Managed CMO’s as single point of contact for FluMist pandemic influenza expansion. Managed purchase order, shipping license and logistics, CMO contracts and worked with a cross functional team to develop alternative nasal delivery design, and completing bridge stability.
- Traveled and worked with European CMO to complete process transfer, cleaning validation quality audit, clinical trial fills, clinical lot approval, deviation support, Pre Factory Acceptance Test (FAT), and FAT for alternative device development.
- Led studies to characterize various device configurations for pre and post FAT test. Traveled to CMO and supervised FAT batch fill.
- Worked alongside clinical group and development team to author the device handling and delivery instruction sheet for clinical use.
- Collaborated with shipping group lead to select vendor (Envirotainer, DLH) for shipping bulk product in portable blending vessel at 2-8 C across continents, providing technical support to shipping and supply chain groups during out-of-specification temperature excursions.
- Completed antiviral efficacy studies of cleaning procedures for multiple vaccine candidates, mitigating potential carry over during strain changing campaigns to site and equipment for clinical manufacturing.
- Established and designed cleaning procedures for European CMO by reviewing cleaning capabilities and executing a cleaning qualification study.
- Conducted cleaning validation of machines and fill lines pre and post production to remove virus from the suites.
- Completed autoclave validation of portable blending vessels by testing holding pressures, autoclave cleaning, and microbial challenge with QC and clinical manufacturing groups.
- Collaborated with US based CMO with cleaning procedures for clinical campaign to product fills for multiple vaccine candidates.
- Completed stability of various polymers, process and technology transfer for feasibility of on Influenza vaccine drug product fills at CMO site.
- CMC sections for IND and BLA were authored and revised for Phase 1 CMV studies, Phase 1 RSV/PIV-3 studies, and Post Market Device comparison study. Submitted data was independently executed; data was gathered and analyzed while working in the formulation development group.
- Investigated and completed deviations/CAPA of failed lots during Phase 1 and Phase 3 clinical production.
- Implemented archival procedure and process for development groups during site shutdown while working with QA to establish an efficient procedure for document archival.
- Member of the FDA and MHRA inspection team. Served as a scribe during both mock and scheduled inspections while working with QA.
- Assisted CMO to gain Swiss medic approval to fill first biologics at plant by completing cleaning validation of suites. Completed the cleaning validation by designing cleaning procedures and executing the study, and summarized results in technical reports.
- Authored/Reviewed QC stability reports, stability summary in technical reports, Raw Material Specifications, and development batch records.
- Authored multiple cleaning validation protocols, and summarized technical/validation reports into AEGIS for clinical manufacturing groups on multiple vaccine candidates to address any potential carry over during campaign changeover.
- Implemented multiple excipient screening stability studies in both lyophilized and liquid format for various vaccine candidates using various analytical techniques.
- Conducted adjuvant and API formulation studies and analytical method development to support single vial subcutaneous delivery format for Phase 1 and Investigational New Drug (IND) filing.
- Designed and carried out Gelatin/Peptide replacement stability study for cell culture influenza and FluMist second generation formulation change. Results were summarized in a technical report for filing.
- Independently conducted blending, holding, freeze thaw, and short term process development studies to support Phase 1 trials. Information presented and provided in regulatory documents and to project teams.
- Executed process development and container closure studies for animal studies, and Phase 1 toxicity for clinical campaign.
- Contributed to FluMist vaccine advancement and research. and pandemic influenza expansion with a cross functional team to develop alternative delivery design, conducted studies to bridge stability in Becton Dickinson (BD) and LDPE Blow Fill Seal nasal devices.
- Performed process optimization ranging from harvest, purification, formulation blending and stability testing.
- Conducted freeze-thaw stability tests on vaccine formulations., thaw-hold, stopper migration, and adsorptive effect on LAV (frozen) stability after change in glass manufacture for FluMist.
- Worked on qualifying virucidal disinfectants to inactivate influenza on various surfaces to support the clinical manufacturing group.
- Performed second generation LAV (refrigerated stable) formulation and stability development and contributed data for BLA Supplement.
- Carried out various buffer selection studies for IND submission. Analysis of buffer properties using DSC profile, Modulated DSC, rheology techniques and physical properties for Phase 1 products
- Led excipient screening and stability studies for PIV3 and RSV candidates. Conducted study design, execution, testing, data collection, technical report summary.
- Compared container closure by droplet size distribution, and rheology analysis in BD nasal Carried out various buffer selection studies for IND submission.
- Worked on frozen LAV to support Phase 3 and IND studies
- Conducted studies on delivery device performance. on droplet size distribution, plume geometry, and rheology analysis on BD nasal delivery device and answered the complete response letter to FDA for delivery device characterization
- Executed stability studies using immunofluorescent assays and tissue culture infectious dose potency assays.
- Conducted multiple formulation and stability studies for LAV market launch.
- Investigated different levels of Nitrogen given at seedling stage on cotton plant growth.
- Work included preparing reagents, making nitrogen-absorbing filters, and logging and organizing raw materials, weighing samples, and equipment clean up.
- Established archiving process for Batch Records of a test strip for blood glucose monitoring, SmartStrip reagent strip to ensure compliance to FDA Quality System Requirement (QSR).
- Reviewed Batch Records for accuracy and compliance. for completeness against cGMP before archiving to Iron Mountain.
- Kept detailed logbook for Batch record reviews. for Batch record reviews thus reducing overall record errors.
- Utilized Excel and Access database to input data for raw materials, reagents, finished goods to aid with SmartStrip shipping and final archive to Iron Mountain.
- (Formerly Medimmune/Aviron)
- Project Management/CMO Management/Device Development/Clinical Manufacturing/
- Regulatory/Quality Assurance Responsibilities
- Formulation and Process Development
- Research Associate II
- Research Associate I
- Laboratory Assistant
- Quality Assurance Analyst, Intern
Quality Assurance Analyst, Intern
Life Scan, a Johnson & Johnson Co
06.1998 - 11.1998
- Established archiving process for Batch Records of SmartStrip reagent strip, ensuring compliance with FDA Quality System Requirement (QSR) and facilitating regulatory audits.
- Verified Batch Records for completeness against cGMP before archiving to Iron Mountain.
- Maintained logbook for Batch record reviews, minimizing record errors and enhancing accuracy of documentation.
- Utilized Excel and Access database to input data for raw materials and finished goods, streamlining SmartStrip shipping and archiving process.
Education
B.S. - Biochemistry
University of California, Davis
Davis, CA01-2001
Regulatory Affairs & Clinical Trial Classes
University of California, Santa Cruz Extension
Santa Cruz, CA01-2013
Skills
- Cleaning validation expertise
- Deviation management
- CMC section review
- Cleaning Validation
- Post Market Surveillance
- Process formulation support
- Regulatory submissions
- Stability and Reagent Handling
- Vendor Management
- Vendor management SAP
- Regulatory Compliance
- Document management
Affiliations
PDA, International Society of Pharmaceutical Engineering (ISPE), BPOG Multi-Product Changeover workstream, and IVT
Timeline
GMP Compliance Expert
Genentech
04.2015 - Current
Sr Validation Engineer
Impax Laboratories
09.2013 - 03.2015
Associate Scientist
AstraZeneca
08.2001 - 09.2012
Quality Assurance Analyst, Intern
Life Scan, a Johnson & Johnson Co
06.1998 - 11.1998
Regulatory Affairs & Clinical Trial Classes
University of California, Santa Cruz Extension
B.S. - Biochemistry
University of California, Davis