Subject matter experience includes regulatory requirements, expectations and industry standards regarding Microbiological QC of drug substance / product, including but not limited to:
Microbiological USP compendial tests and guidance chapters, including: 51, 55, 60, 61, 62, 71, 81, 85, 788, 1072, 1111, 1112, 1113, 1115, 1116, 1117, 1207, 1208, 1211, 1223, 1227, 1229, 1231. regarding the following: aseptic processing guidelines, validation of microbial methods (conventional and rapid testing for sterility & microbial limit testing), environmental monitoring and control, disinfectant efficacy qualification, compressed gases and source water / purified water system qualification, Environmental Monitoring for: aseptic processing, terminal sterilization, non-sterile manufacturing and pharmaceutical compounding (503B). ISO 14644-1, barrier isolator qualification, steam quality (EN285); familiar utilities include: Celsis Advance (Rapid Micro Method), MIDI, Vitek Malti-TOF, DuPont Riboprint, MicroSeq, Biolog, Documentum, TrackWise, Siemens BMS, JDE, SAP, Kaye Validator; process validation experience include: isolator VHP and room-fogger H2O2 decontamination, media fill simulation, sterility assurance (moist heat, dry heat, irradiation); practical chemistry experience includes rudimentary wet chemistry and identification testing e.g. IR / UV spec, LOD, KF, TLC, HPLC GC and TOC; incoming inspection of components: stoppers, caps and of glass vials per PDA TR 43 and related component quality inspection: container-closure integrity testing; experience, scholarship and training elements include: root cause analysis, FMEA investigational methodology, CMC, technology transfer, field alerts, consent decree, import alert; Lean Six Sigma, US Pharmacopeial Forum (PF) online member and PDA devotee. Routine regulatory inspection and PAIs.
Professional Experience INDEPENDENT CONSULTANT MAR 2011 – PRESENT
2011-2013 Upstate NY: Responsible for transport-related deviations; member of Global Auditing and Compliance team in remediation of Warning Letter
2013 - Cleveland, OH – Audited QC Micro lab and reviewed aseptic processing in remediation of Consent Decree for parenteral manufacturer
2013 - Richmond Hill, Ontario – Assisted with Aseptic processing and QC Micro lab issues from Warning Letter for Canadian Ophthalmic manufacturer
2014 - Lexington, KY – Interim manager for QC Micro during preparation for and successful execution of FDA Pre-Approval Inspection of domestic intranasal manufacturer
2015 - York, Ontario – Auditing GMP operations in remediation of Warning Letter for parenteral manufacturer.
2015 - Chengdu, China - Pre-approval mock audit for Biotech manufacturer
2016-2019 - Pune, India – Interim QC Micro manager for solid oral dosage unit; certification auditing and batch record review team for parenteral manufacturing units to resolve import ban
2019-2020 Houston, TX – outsourcing compounding facility; led major microbiology and aseptic processing projects for resolving consent decree; client opted to divest from the 503B industry.
2021 - Lexington, KY- Working on team to bring aseptic processing for production in clinical phases II and III anti-COVID vaccine – project on indefinite hold with phase I failure.
MANAGER, QUALITY CONTROL, AUG 2008 – MAR 2011
Kanghong-Sagent Pharmaceutical, Chengdu, P.R. China (dba: Sagent Pharmaceuticals, China)
Greenfield project, in Chengdu, PRC: Led the planning and execution of the quality control departments (Micro and Chemistry) for a joint venture US-China parenteral manufacturing facility in compliance with FDA / EMEA; staffed both micro and chem labs; scheduled project timelines related to QC for: CMC, process qualifications: compressed gases, water system and cleanroom, supplier qualification; qualified vendors, initiated and managed budgets for laboratories’ start-up; created SOP schedule; developed training programs and trained personnel in basic microbiology, laboratory / aseptic techniques, cleanroom behavior and general cGMPs; developed strategy for source water testing; audited suppliers; implemented clean steam quality testing.
MANAGER, QUALITY CONTROL, JUL 2006 – DEC 2007 Cardinal Health / Catalent Pharma Solutions, San Diego, CA
Successfully led QC labs during FDA and EMEA pre-approval inspection in June (FDA) and October (EMEA) 2006; remedied audit items including upgrading fill-finish separation barriers and airflow visualization studies vital to facility approval; represented QC labs as a member of the Objectives Management Team; on-time objectives rate of >92% while supervising 5 microbiologists and chemistry technician and supervisor; generated and executed change control to test TOC of purified water in-house vs. costly out-sourcing; composed EM sample site location rationale.
INDEPENDENT CONSULTANT, MAY 2004 – JUL 2006
Consulting Firm Mundelein, IL
Various roles included Operations / QC supervision and technical duties: environmental monitoring, cleaning / disinfection program, development and validation of H2O2 fogging method; EtO BIER / D-value testing, steam sterilization processes, aseptic filling and biological isolator / barrier systems; cleaning processes for endoscopes and in developing standardized cleaning efficacy analyses; investigated complaints program for major large volume parenteral drug manufacturer; supervised manufacturing staff during manufacture of combination medical device / biological hemostat; supervised microbiologists in preparation for transition from clinical to market production of parenteral.
MICROBIOLOGY, Q.C. Microbiology Manager, OCT 2003 – MAY 2004 NeoRx Corporation, Denton, TX
Microbiological Laboratory start up for Phase III clinical production; validation of Sterility, LAL and Bioburden testing for a radiological parenteral; executed performance qualification of environmental monitoring program; directly after having departed, the project folded upon failure to enroll patients in the clinical trial.
MICROBIOLOGY PROFESSIONAL, AUG 2000 – OCT 2003 Allergan Pharmaceuticals, Waco, TX
Shared in supervision of 15 microbiologists; composed aseptic training program for operators; investigated sterility test failures; qualified alternative nutritive medium (R2A) for testing water; upgraded microbial identification system (MIDI) with GC system hard and software upgrade; qualified
sanitizers; Batch Product Review for QC Micro and release; autoclave load qualification; implemented procedures for use of precision pipettors, including gravimetric calibration; Bacteriostasis / Fungistasis suitability for sterility, microbial limit and antimicrobial efficacy tests; validated spectrophotometer method for use in enumerative micro assays; periodic requalification, operation and maintenance of sterility test isolator / VHP equipment; organized maintenance and spare parts for isolators and qualified alternate vendor (Micron) for maintenance of isolators, hosted regulatory agents (FDA, MCA, MHRA, TGA etc.) for routine inspections, internal audits; member of review team for implementation / validation for new LIM system for laboratory processes.
SENIOR MICROBIOLOGY TECHNICIAN, DEC 1997 – AUG 2000 Colgate Oral Pharmaceuticals, Dallas, TX
Validated Microbial Limit testing for various product formulations and raw materials using rapid methods; Preservative Efficacy testing; composed protocols and executed IQ, OQ and PQ for Anatel 643p TOC device for in-line monitoring of purified water; trained and qualified in QC chemistry testing methods including USP tests for identity and purity for many excipients and actives; initiated and validated ultra-low temperature technique for long-term maintenance of microbial cultures; qualified rapid Microbial Limit testing (Celsis Advance); Microbiological testing of pharmaceutical water Microbiological Identification tests by API and Biolog, growth promotion testing, microbial enumeration / interpretation of results
MICROBIOLOGY TECHNICIAN, Lab Support, Dallas, TX, 1996 -1997
QC Microbiology at Miller Brewery, Ft. Worth, TX; Aloe Vera Int’l, Carrollton, TX, Colgate Oral Pharmaceuticals, Dallas, TX
MICROBIOLOGY TECHNICIAN, Analytical Food Laboratories, Grand Prairie, TX, 1995 -1996 Media prep and food microbiology technician; FDA Bacteriological Analytical Manual
Education / Certification
B.S., Microbiology, University of Texas, Arlington, December 1995
Certified Microbiologist, National Registry of Microbiologists, June 2000
Certified Specialist Microbiologist, National Registry of Microbiologists, June 2004
Certified LSS, Green Belt, Purdue University, November 2011
Certified LSS, Advanced Tools and Methods, Purdue University, April 2012