Experience

Microbiology Consultants, LLC, Lutz, Florida
President
February 2009 to present

Provide technical, regulatory, quality and compliance support for the pharmaceutical, biotech, gene and cell therapy, medical device, personal care and other regulated industries. Develop microbiological monitoring, control and continuous improvement strategies for API and fill-finish manufacturing, fermentation, recovery and purification, and aseptic processing and non-sterile manufacturing. Design and administer microbiological programs including environmental monitoring, investigations of laboratory and manufacturing microbial excursions and out-of-specification findings, laboratory audits, optimization and management, laboratory and facility design and qualification, cGMP compliance, Pharmacopoeia compliance, barrier isolator design and microbiological validation, microbiology method and protocol development, validation and technology transfer, contact lens care formulation development, manufacturing, stability testing and product release, disinfection, sterilization and the use of biological indicators, cleaning validation, process development, regulatory audit response and management (e.g., FDA 483, Warning Letter, Consent Decree, product recalls), regulatory dossier development support, and Process Analytical Technology (PAT). Support microbiology and rapid microbiological method suppliers and industry end-users in developing next generation technology platforms, validation and testing plans, financial and return on investment (ROI) strategies, commercialization approaches, and global regulatory and pharmacopoeia compliance. Provide guidance on investigations, remediation and risk assessments for microorganism recovery in nonsterile finished product, including those involving Burkholderia cepacia complex (BCC) and other objectionable organisms. Act as subject matter expert for microbiology technology companies during due diligence, partnership, collaboration, merger, and acquisition activities. Expert witness for matters related to pharmaceutical microbiology, ophthalmic formulations, contamination control, antimicrobial and preservative effectiveness, sterilization, pharmacopoeia interpretation and compliance, USP microbiology test methods, laboratory, and manufacturing GMPs, formulation development and stability, sterile and nonsterile manufacturing, research and development, and product quality.

Eli Lilly and Company, Indianapolis, Indiana
Director, Microbiology Leader and Senior Research Fellow
Manufacturing Science and Technology
October 2003 to February 2009

Provide technical and strategic leadership for microbiology and Process Analytical Technology (PAT) across all Manufacturing networks (Parenteral, Drug Product, Small and Large Molecule Bulk API) and in Product Research & Development. Support the development and technology transfer of new molecules and processes while aligning these activities with Lilly's Single Process Map, Quality by Design (QbD) and World Class Commercialization programs. Partner with Quality, Engineering, Operations and Development to ensure that the company meets or exceeds industry standards and regulatory expectations from a microbiological and sterility assurance perspective. Focus on the interface between Manufacturing and Development as microbiological control strategies are defined for new products, production facilities and contract manufacturers. Champion efforts to assess and implement new technologies and corporate manufacturing strategies that are aligned with GMPs for the 21st Century and Quality by Design (QbD) initiatives, including PAT applications, rapid microbiological methods and barrier isolator manufacturing platforms. Partner with Global Quality Control Laboratory Microbiology Validation function to develop and implement next generation QC microbiology in-process bioburden, raw material, finished product and environmental monitoring platforms. Develop and maintain highly capable and dedicated PAT staff comprised of Ph.D. Research Scientists, Analytical Chemists and Technical Associates, maintain function's annual budget, and conduct performance appraisals. Guide subordinates in carrying out responsibilities and provide adequate resources to ensure that the PAT function is capable of supporting the network's goals and objectives. Influence changes to microbiology, sterility assurance and PAT industry best practices through external interactions with professional and international compendial organizations. Interface with the FDA PAT team, CDER compliance and review microbiology staff and international regulatory authorities to influence change to future dossier/submission expectations and a reduction of regulatory review requirements that are aligned with Lilly's long-term product development and manufacturing strategies.

Pharmaceutical Systems, Inc., Mundelein, Illinois
Vice President, Consulting
February 2002 to September 2003

Responsible for consulting, developing and implementing pharmaceutical manufacturing, QA/QC and regulatory solutions in all areas of medical device and pharmaceutical operations including sterilization, aseptic and non-sterile compounding and filling, Research & Development, microbiology, environmental monitoring, isolator/barrier systems, GMP/QSR compliance, QA/QC, regulatory submissions, manufacturing and laboratory start-up operations and regulatory compliance. Directly manage the activities for more than 20 consultants at a major pharmaceutical manufacturing facility under consent decree.

Bausch & Lomb, Rochester, New York
Director, External Technology
Global Vision Care
October 2000 to January 2002

Identify external commercialization, new product development, joint-ventures, licensing and acquisition opportunities that are consistent with the strategic direction within Bausch & Lomb's Vision Care, Pharmaceutical, Surgical, General Eye Care and Vision Accessories business units. Interact directly with the company's Global Category Leaders, Corporate Business Development and Legal, and the commercial functions within each business unit. Represent the Company in negotiations and leverage its position with external clients and other companies via business initiatives and acquisitions and alliances. Coordinate technical due diligence activities within the Research & Development, Engineering and Commercialization/Marketing organizations. Act as United States Delegate on ISO Technical Committee 172; Optics and Ophthalmics.

Bausch & Lomb, Rochester, New York
Director, Biological and Sterilization Sciences
Global Vision Care
January 1997 to September 2000

Lead Global Microbiology, Toxicology and Sterilization Core Competencies supporting Bausch & Lomb's Vision Care, Pharmaceutical and Surgical Divisions worldwide. Support R&D new product development management process (contact lens, lens care, general eye care, ophthalmic pharmaceuticals, surgical devices), new product strategic direction, global product stability, and on-site product performance (e.g., with LASIK surgeons). Direct all microbiological and toxicological pre-clinical testing for Vision Care Division. Support global Operations (product release, process improvements, validation, training, laboratory start-up, troubleshooting), New Product Business Development (technical due diligence), Marketing (product claims, publications, professional meeting presentations) and Quality (internal and external lab and manufacturing audits/issues, ISO certification, domestic and International Quality Systems; ISO 9001, EN 46001, GMP). Support Regulatory Affairs (510k, PMA, CE submissions, product returns, field issues), and Legal (patent support, product litigation, competitive claims). Identify and evaluate external technologies, research collaborations, and products and processes that are consistent with the Corporation's long-term vision. Technical support during ISO and FDA audits. Maintain financial accountability for the function. Serve as Corporate liaison for ISO/AAMI Sterilization Standards Committees and a United States Delegate on ISO Technical Committee 172; Optics and Ophthalmics.

Bausch & Lomb, Rochester, New York
Manager, Research Microbiology
Global Vision Care
March 1994 to December 1996

Direct Senior Scientist staff in support of Global Research & Development for Contact Lens Care, General Eye Care, Device and Health Care sectors. Project Manager for Disinfection Research, High Throughput Screening Core Technologies and other product development management teams. Provide support for domestic (510k, PMA) and International registration of Contact Lens and General Eye Care products. Start-up, audit (cGMP/ISO) and certify analytical laboratories and manufacturing sites worldwide. Primary Microbiology contact during FDA on-site, pre-approval and GMP inspections. Direct terminal sterilization validation studies for medical device sector. Corporate consultant for on-site global Microbiology issues (manufacturing, aseptic processing, sterilization, process improvements, regulatory and GMP compliance, environmental monitoring, marketing). Microbiology Core Technology for container/closure and preservative-free multi-dose delivery systems. Corporate liaison for ISO/TC 198 (Sterilization of Health Care Products), U.S. delegate for ISO/TC 172 (Contact Lenses; U.S. Expert for Microbiology Committee), ANSI, and FDA standards development committees. Manage cost/budgets for laboratory and product development projects. Manage radioisotope testing facility. Certified ISO 9000 auditor for Division.

Bausch & Lomb, Rochester, New York
Manager, Quality Assurance Microbiology
Personal Products Division
August 1991 to February 1994

Direct exempt and non-exempt scientists and technicians. Support Corporate manufacturing and engineering units (contamination control, environmental monitoring, terminal sterilization validations). Direct release and stability testing of devices and aseptically filled products for Personal Products, Contact Lens and Pharmaceutical Divisions worldwide. Review laboratory compliance issues; modify existing and create new systems to comply with current GMPs and International compendial guidelines. Responsible for personnel training and start-up of Microbiology analytical laboratories and manufacturing sites. Audit and certify contract laboratories. Supervise barrier technology sterility test workstation and vaporized hydrogen peroxide bio-decontamination system. Coordinate consumer affairs microbiology testing. Act as consultant on quality issues, troubleshooting, and standards review and development. Primary Microbiology contact during FDA on-site, pre-approval inspections. Represent Corporation on AAMI - ISO Technical Committee 198 - Sterilization of Health Care Products.

Johnson & Johnson Medical, Inc., Arlington, Texas
Manager, Senior Microbiologist
Research & Development
July 1988 to July 1991

Direct personnel in support of new product development for emerging hospital sterilization technologies (STERRAD peroxide/plasma system). Develop process validations for medical device sterilization. Interact with hospital administration and central supply during clinical trials of new sterilization technologies. Provide documentation of analytical test procedures, corresponding data and interpretations for FDA 510(k) submissions. Support the development of pre-clinical studies for advanced wound care products.

Education

Ph.D. Microbiology and Biochemistry. GEORGIA STATE UNIVERSITY, Atlanta, Georgia, 1988
Doctoral Dissertation: Adherence of Pseudomonas aeruginosa to Contact Lenses.

B.A. Anthropology and Sociology (double major). Chemistry (minor). HOBART COLLEGE, Geneva, New York, 1983

Awards and Honoraria

2018. Martin VanTrieste Pharmaceutical Science Award, Parenteral Drug Association (PDA)
2014. Distinguished Editor Award, Parenteral Drug Association (PDA)
2008. John Henry Hobart Fellow in Residence for Ethics and Social Change, Hobart and William Smith Colleges
2006. Distinguished Service Award, Parenteral Drug Association (PDA)
2006. Microbiologist of the Year, Institute for Validation Technology (IVT)

Professional Affiliations (current)

Parenteral Drug Association (PDA)
Parenteral Drug Association (PDA): Co-chair, Technical Report #33 Task Force

Professional Affiliations (past)

Advisor to United States Pharmacopeia (USP); Modern Microbiological Methods Expert Panel
American Society for Microbiology (ASM)
International Society for Pharmaceutical Engineering (ISPE)
Contact Lens Association of Ophthalmologists (CLAO)
Contact Lens Institute (CLI)
British Contact Lens Association (BCLA)
American Association of Optometry (AAO)
Association for Research in Vision and Ophthalmology (ARVO)
United States Delegate, ISO Technical Committee 172, Optics and Ophthalmics
Committee member, Association for the Advancement of Medical Instrumentation (AAMI)
Committee member, American National Standards Institute (ANSI), Z80 Ophthalmics
ISO Technical Committee 198, Sterilization of Health Care Products
USP Technical Committee 18, Working Group 6 (Rapid Microbiological Methods)

Academic Affiliations

Alumni Council, Hobart College, Geneva, New York (Current)
Adjunct Professor, Department of Biology, Georgia State University, Atlanta Georgia (Past)
Adjunct Professor, School of Optometry, University of Waterloo, Ontario, Canada (Past)

Editorial Review and Advisory Boards

American Pharmaceutical Review
European Pharmaceutical Review
PDA Journal of Science and Technology

Expert Witness, Deposition and Trial Testimony

• 2022. Regeneron Pharmaceuticals, Inc. v. Novartis Pharma AG, Novartis Technology LLC, Novartis Pharmaceuticals Corp. Case IPR2021-00816.
• 2020. Christina King and Klay King, individually and as Co-Personal Representatives of the Estate of Stephen King, deceased, v. Pharmatech, LLC; Raidel Figueroa; The Havard Drug Group, LLC dba Rugby Laboratories; Bayshore Pharmaceuticals, LLC. Case No. CACE 17-017934
• 2019. Frances Ruiz as Personal Representative of the Estate of Luis Ruiz, deceased, v. Teva Pharmaceuticals USA, Inc.; Teva Parenteral Medicines, Inc.; Teva Pharmaceutical Industries, Ltd.; AmerisourceBergen Drug Corporation; Blue Medical Supply, Inc.; Jay Harlan Epstein, M.D.; Anesthesia Associates of Pinellas County, P.A. Hillsborough County, Florida Case No. 11-005957
• 2016. Senju Pharmaceutical Co., Ltd., Bausch & Lomb Incorporated, and Bausch & Lomb Pharma Holdings Corp. v. Lupin, Ltd., and Lupin Pharmaceuticals, Inc. Civil Action File Nos. 1:14-cv-00667-JBS-KMW, 1:14-cv-04149-JBS-KMW, 1:14-cv-05144-JBS-KMW, 1:15-cv-00335-JBS-KMW; Innopharma Licensing, Inc., Innopharma Licensing, LLC, Innopharma, Inc., Innopharma, LLC, Mylan Pharmaceuticals, Inc., and Mylan Inc. Civil Action File Nos. 1:14-cv-06893-JBS-KMW, 1:15-cv-03240-JBS-KMW
• 2013-2014. Astrazeneca LP and Astrazeneca AB v. Apotex, Inc. and Apotex Corp. Civil Action File No. 1:09-CV-1518 (RMB) (AMD) (Appeal)
• 2014. Apotex Corp. v. Alcon Research, Ltd. Case IPR2013-00428, 00429 and 00430
• 2014. United Therapeutics Corp. v. Sandoz Inc. et al. Civil Action File No. 12-1617 (PGS) (LHG) and 13-316 (PGS) (LHG)
• 2013. Alcon Canada Inc. and Alcon Research, Ltd. and Apotex Inc. and The Minister of Health. Court File No. T-1667-12
• 2013. Peter Robertson and Kindra Robertson v. McNeil-PPC, Inc. and Johnson & Johnson, and DOES 1. Case No. 2:11-CV-09050-JAK-SS
• 2009-2012. Astrazeneca LP and Astrazeneca AB v. Apotex, Inc. and Apotex Corp. Civil Action File No. 1:09-CV-1518 (RMB) (AMD)
• 2011. Alcon Research, Ltd. v. Barr Laboratories, Inc., Par Pharmaceutical, Inc. Civil Action No. 09-318-LDD (Consolidated)
• 2009-2010. Aletia Moon and James Zachary Carrier v. Advanced Medical Optics, Inc. Civil Action File No. 4:08-CV-021-HLM

Publications

Dr. Miller is the Editor of the PDA Encyclopedia of Rapid Microbiological Methods and has authored numerous publications and book chapters on rapid microbiological methods, environmental monitoring, isolator technology, PAT, regulatory submission strategies, disinfection and ophthalmics. Click here to view a complete list of his publications.

Presentations

Dr. Miller has presented at numerous PDA, ISPE, ECA, IVT, IBC and other worldwide technical organization meetings. Presentations have focused on rapid microbiological methods, pharmaceutical microbial control strategies during product development and manufacturing, environmental monitoring, isolator technology, PAT and regulatory submission strategies. Click here to view a complete list of his presentations.

Chairperson Appointments

Dr. Miller has served as chairperson for numerous international technical conferences. The following list represents his recent appointments:

• 2020. PDA Workshop on Rapid Microbiological Methods. Virtual meeting.
• 2019. PDA Workshop on Rapid Microbiological Methods. Bethesda, Maryland
• 2018. PDA European Conference on Pharmaceutical Microbiology. Berlin, Germany
• 2017. PDA European Conference on Pharmaceutical Microbiology. Porto, Portugal
• 2015. PDA European Conference on Pharmaceutical Microbiology. PBerlin, Germany
• 2014. PDA European Conference on Pharmaceutical Microbiology. Berlin, Germany
• 2013. PDA European Conference on Pharmaceutical Microbiology. Berlin, Germany
• 2012. PDA European Conference on Pharmaceutical Microbiology. Berlin, Germany
• 2008. PDA 3rd Annual Global Conference on Pharmaceutical Microbiology. Chicago, Illinois
• 2007. PDA Global Conference on PAT. PDA, Bethesda, Maryland
• 2007. PDA Global Conference on Rapid Microbiological Methods. PDA, Verona, Italy
• 2006. PDA 1st Annual Global Conference on Pharmaceutical Microbiology. PDA, Bethesda, Maryland
• 2005. Global Compliance Strategies for Rapid Methods in Pharmaceutical and Biopharmaceutical Manufacturing, Barnett International, Brussels, Belgium
• 2005. 7th Annual Advancing Technologies in Rapid Methods for Pharmaceutical and Biopharmaceutical Manufacturing, Barnett International, Washington, DC
• 2004. Rapid Microbial Methods, IBC Life Sciences, San Diego, California
• 2004. Rapid Microbiological Methods, Institute for Validation Technology (IVT), Amsterdam, The Netherlands
• 2004. Addressing FDA's Full Support of Rapid Methods, Barnett International, Philadelphia, Pennsylvania
• 2003. Rapid Microbiological Methods, IVT, Dublin, Ireland
• 2002. Rapid Microbiological Methods, IVT, Amsterdam, The Netherlands
• 2001. Strategies for Automation, Detection and Validation of Microbiology Test Methods, Barnett International, Philadelphia, Pennsylvania
• 2001. PDA Spring Meeting, PDA, Las Vegas, Nevada
• 2001. Rapid Methods & Automation in Microbiology, Barnett International, San Juan, Puerto Rico
• 2000. Rapid Methods & Automation in Microbiology, Barnett International, Brussels, Belgium
• 1999. Microbiology of the Eye Symposium, Annual Meeting, American Society for Microbiology (ASM), Chicago, Illinois