Senior Vaccine Development & Manufacturing Engineer

SENIOR VACCINE & BIOLOGICS PRODUCT DEVELOPMENT & MANUFACTURING PROFESSIONAL

EXECUTIVE SUMMARY

Innovative and goal oriented Senior Product Development and Manufacturing Professional who offers a distinguished background in technical support of sterile cGMP manufacturing, technical transfer, scale-up, manufacturing compliance, and process optimization. Exceptional communicator with strong problem resolution skills. Sought-after author and speaker for lyophilization and emerging alternatives.

CORE COMPETENCIES

Lyophilization of pharmaceuticals and biologics

Spray drying of pharmaceuticals and biologics

Aseptic processing

Research & Development

Strategic Planning & Organizational Leadership

Regulatory Compliance

Project Management

Process Optimization, Reengineering & Change Management

Deviation Investigation & Resolution, CAPA

Budget Forecasting & Planning

Cost/Benefit Analysis

EMPLOYMENT

Cobax, Lousville, CO 2010-Present

Cobax is developing an FDA-approved, orally delivered spray-dried live bacteriotherapy product for prevention of recurrent infection with Clostridium difficile, which causes up to 40,000 deaths per year in the U.S.

VP, Product Development

Leading Cobax’s manufacturing product development activities for powdered live bacteria to be administered in an enteric coated capsule. Currently engaged in funding discussions with leading venture capital firms.

AKTIVAX, Boulder, CO 2010-Present

AktiVaxTM is creating a paradigm shift in vaccine delivery by providing an alternative to the traditional syringe and vial system. We are developing an innovative vaccine delivery platform that integrates stable spray-dried vaccine powers and diluent for reconstitution in the same single-use, single-dose device.

SVP, Vaccine Process and Formulation Development

Leading AktiVax’s formulation and process development activities for powdered vaccines to be filled into an innovative reconstitution/delivery device. Currently engaged in intensive business plan development and partnering discussions with a number of medium to large-sized vaccine manufacturers.

AKTIV-DRY LLC, Boulder, CO 2005-2010

Start-up company with 10 employees known for developing an inhaled dry powder live measles vaccine, an inhaled dry powder protein-conjugate vaccine against nicotine and commercializing a new pharmaceutical powder manufacturing technology

Director of Process and Product Development

2 Direct Reports, $2M Annual Budget

High profile director charged with manufacturing implementation of a new measles vaccine and dry powder inhaler, which included leading scale-up, cGMP development, technical transfer of spray drying, and cGMP manufacturing of inhalers. Wide range of business development and administrative responsibilities as well.

Secured a $923K Small Business Innovation Research grant for development of a new nicotine vaccine. Oversaw initial vaccine development that has to-date culminated in superior immunogenicity in rats.

Successfully completed cGMP process and equipment development and transfer to the Serum Institute of India.

Obtained and executed R&D contracts for formulation/process development from multinational food and vaccine companies.

ELI LILLY & CO., Indianapolis, IN 2002-2005

Principal Research Scientist (2005-2005)

Senior Research Scientist (2004-2005)

Research Scientist (2002-2004)

2 Direct Reports, $1M Annual Budget

Responsible for global freeze-drying manufacturing technology implementation and support.

Conceived of, obtained company funding for, then led process advancement for optimization of freeze drying cycle for Gemzar 1g (a $1.2BN/yr product). This initiative diminished cycle time by 28%, amplified freeze drying plant capacity by 23% and eliminated need for a new $200M freeze drying plant.

Pioneered and steered company-wide lyophilizer capacity testing program that tested freeze dryer capabilities as part of optimization project.

Discovered, published and presented to in international conference audience the finding of "choked flow" during the freeze drying process.

Spearheaded freeze drying scope of process technical transfers to two Eli Lilly facilities and contract manufacturers.

MERCK & CO., INC., West Point, PA 1994-2002

Senior Process Engineer and Team Leader

4 Direct Reports, $200K Annual Budget

Led manufacturing implementation of a new sterile live virus vaccine that included engineering lots, media fills, closure integrity testing, batch records, change control, tube irradiation sterilization and incoming supplies inspection, process validation protocol, project timelines, and validation lots.

Provided advanced technical support for formulation, filling, freezing, and lyophilization of all Merck live virus vaccines.

Led team that provided VARIVAX bulk technology and engineering support, process troubleshooting, atypical resolution, process monitoring, batch record maintenance, process validation, and process change control.

Engaged with operations and quality control to achieve atypical processing report reduction of 38%, while sustaining on-time ratings, corrective action close-out, and batch record revision at 100%.

Directed a particulate investigation team that reduced particulate atypical processing events by 60%.

Introduced a departmental project prioritization and tracking business process that improved project prioritization and departmental effectiveness.

Successfully directed the design, fabrication; factory acceptance testing, site acceptance testing; installation and operational qualification; clean in-place, sterilize in-place, and thermal decontamination cycle validations; sterile challenge media fills; and 5 engineering lots and 3 consistency lots for an automated vaccine sonication and filtration system. Product yields were approximately 4-fold higher than the previous manual process.

Took the initiative to conduct early safety and HAZOP (hazard and operability) studies that resulted in many cost-effective design and safety improvements.

Led a team that coordinated all aspects of a change in the multiplicity of infection (MOI) for the manufacture of new live virus vaccine bulk stock seeds. The project included a license supplement and virus genetic, biologic, and biochemical characterizations. The team met all milestones, including the successful production and pooling of the stock seed and production of 5 demonstration lots.

Used alternate roller-bottle rotation rate strategies to identify the potential for >30% higher-yields for VARIVAX(R) through manipulation of roller bottle rotation rates. Worked with Rutgers University to mathematically model the process. Presented the results at national meetings, co-authored a patent application and a publication in Biotechnology and Bioengineering.

Provided Rubella vaccine bulk production support, including atypical process report resolution and manufacturing process description updates and improvements. Established an excellent customer support relationship with production. Decreased atypical process report resolution time by 86%.

Coordinated, authored, and obtained approval for the varicella facility upgrade project that enabled construction and qualification in processing suites in one part of the facility without interrupting cGMP bulk manufacture in adjacent suites

EDUCATION

Ph.D. Chemical Engineering, GPA 3.9/4.0, University of Colorado, Boulder, CO

Thesis: Heterogeneity Phenomena in Pharmaceutical Freeze-Drying

M.S. Chemical Engineering, GPA 3.9/4.0, University of Colorado, Boulder, CO

Thesis: Inclined Sedimentation Perfusion for Suspension Cultures of Recombinant Mammalian Cells

AWARDS AND FELLOWSHIPS

Eli Lilly Manufacturing Science and Technology Technical Excellence: 2005

Merck & Co., Inc. Ph.D. Fellowship: 1998-2000

Merck & Co., Inc. Awards for Excellence: 1995, 1996

Graduate Fellowships, Colorado Institute for Research in Biotechnology: 1992-93

Omega Chi Epsilon Chemical Engineering Honor Society: 1991

NIH Biotechnology Training Fellowship: 1990-1992

Honor Graduate, U.S. Army Officer's Basic Course: 1987

Distinguished Military Graduate, Army Reserve Officer's Training Corps: 1986

Full-Tuition Scholarship, Army Reserve Officer's Training Corps: 1984-86

Top Science Student Award, Chaminade College Preparatory School in St. Louis, MO: 1981

AFFILIATIONS

Founding member, AAPS focus group steering committee "Freezing & Drying Technologies”

Proposal Reviewer, National Institutes of Health

Journal article peer reviewer for the Journal of Pharmaceutical Sciences, Vaccine, International Journal of Pharmaceutics, AAPS PharmSciTech, and Pharmaceutical Development and Technology

Member, AAAS, AAPS, ACS, PDA, ISPE

MILITARY

First/Second Lieutenant, UNITED STATES ARMY 1986-1990, Various locations, including 3 years in Germany. Top Secret / Background Investigation security clearance, Personnel Reliability Program

BOOK CHAPTERS

Searles, JA (2010) "Optimizing the throughput of freeze-dryers within a constrained design space." in Freeze drying / Lyophilization of Pharmaceutical and Biological Products 3rd edition. Marcel Dekker, Ed. L. Rey and J. May

Searles, JA (2010) "Freezing and annealing phenomena in lyophilization." (updated for 3rd edition) in Freeze drying / Lyophilization of Pharmaceutical and Biological Products 3rd edition. Marcel Dekker, Ed. L. Rey and J. May

Searles, JA and Mohan, D (2010) "Spray Drying of Biopharmaceuticals and Vaccines" in Formulation and Process Development Strategies for Manufacturing of a Biopharmaceutical, edited by Feroz Jameel and Susan Hershenson

Jameel, F and Searles, JA (2010) "Development and Optimization of Freeze Drying Processes in Formulation and Process Development Strategies for Manufacturing of a Biopharmaceutical, edited by Feroz Jameel and Susan Hershenson

Searles, J.A. (2004) "Freezing and annealing phenomena in lyophilization," in Freeze drying / Lyophilization of Pharmaceutical and Biological Products 2nd edition. Marcel Dekker, Ed. L. Rey and J. May

Searles, JA; Todd, P; and Kompala, DS (1994) "Perfusion culture of suspended CHO cells employing inclined sedimentation" Animal Cell Technology: Products of Today, Prospects for Tomorrow, ed. Spier, RE, Butterworth Heinemann, Oxford, UK

PAPERS AND PATENTS

Kisich, KO, Higgins, MP, Park, I, Cape, SP, Lindsay, L, Bennett, DJ, Winston, S, Searles, JA and Sievers, RE “Dry powder measles vaccine: particle deposition, virus replication, and immune response in cotton rats following inhalation” Vaccine- accepted for publication

SL Nail, JA Searles (2008) "Elements of Quality by Design in Development and Scale-Up of Freeze-Dried Parenterals", BioPharm, 21(1) January, p. 44

R.E. Sievers, B.P. Quinn, S.P. Cape, J.A. Searles, C.S. Braun, P. Bhagwat, L.G. Rebits, D.H. McAdams, J.L. Burger, J.A. Best, L. Lindsay, M.T. Hernandez, K.O. Kisich, T. Iacovangelo, D. Kristensen, D. Chen. (2007) "Near-critical Fluid Micronization of Stabilized Vaccines, Antibiotics and Anti-virals", J. Supercrit. Fluids, 42(3), 385-391

Searles, JA, (2004) "Observation and Implications of Sonic Water Vapor Flow During Freeze Drying," American Pharmaceutical Review, 7(2) pp 58-68 and 75.

Searles, J.A. (2003) "Lyophilization- an essential technology." European Pharmaceutical Review, 4, 77-81.

JA Searles, JF Carpenter, TW Randolph, (2001) "The Ice Nucleation Temperature Determines the Primary Drying Rate of Lyophilization for Samples Frozen on a Temperature-Controlled Shelf", J. Pharm. Sci., 90(7), 860-871

JA Searles, JF Carpenter, TW Randolph, (2001) "Annealing to Optimize the Primary Drying Rate, Reduce Freezing Heterogeneity, and Determine Tg' in Pharmaceutical Lyophilization", J. Pharm. Sci., 90(7), 872-887

Bramble, J.L.; Muzzio, F.J.; Searles, J.A. (2000) "Method of improving mixing in roller bottles." United States Patent 6,096,544.

Searles, JA, Carpenter, JF; and Randolph, JW (2000) "Primary drying rate heterogeneity during pharmaceutical lyophilization" American Pharmaceutical Review, 3(3), 16-24.

FJ Muzzio, DR Unger, M Liu, J Bramble, JA Searles, P Fahnestock (1999) "Computational and Experimental Investigation of Flow and Particle settling in a Roller Bottle Bioreactor", Biotech. and Bioeng., 63(2), 185-196

JA Searles, P Todd, DS Kompala (1994) "Viable Cell Recycle with an Inclined Settler in the Perfusion Culture of Suspended Recombinant CHO Cells", Biotech. Prog., 10, 198-206

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