Committee & Presenter Biographies

With more than 15 years of experience in the biotech industry, including positions at Genentech, Regeneron and Lonza, I am an experienced Business Development Director at ten23 health.

My expertise lies in external collaborations, alliance management, and pharmaceutical development, specifically in the areas of formulation development and in-use stability and compatibility. At ten23 health, my primary focus is to identify new business opportunities for the company, build the ten23 brand and provide strategic and tactical guidance to our Development teams.

I began my career as a Research Associate at Regeneron and Genentech, where I worked on Eyelea (Aflibercept), Praluent (Alirocumab) and Polivy (Polatuzumab vedotin). I played a pivotal role in establishing the technical operations team at ten23 health and Lonza Drug Product Services. I have successfully led multiple CMC programs and collaborated with both small and large pharmaceutical companies at various stages of development.

Above all, my true passion lies in creating innovative solutions that enhance patient outcomes and experiences.

Dominique Bauert holds a Master of Science degree in mechanical engineering and has been working for more than 10 years in the Pharma and Medical device industry. After he spent 3 years in Singapore, where he was responsible for the Asia Pacific Office of a medical device company, he joined SCHOTT as Global Business Development Manager cartridges in the year 2016 and moved to St. Gallen, Switzerland. After one year, he took over the role of Head of Business Development for Cartridges. In the year 2020, Dominique became the Head of Business Development Sterile Solution where he is the leading person for the market development of ready-to-use cartridges and vials.

Dominique has more than 15 years experience in sales, innovation and product management.

He is a professional speaker at many conferences and seminars on topics related to parenteral primary packaging and drug delivery devices. He has written several white papers.

Zachary Beck joined the Eurofins BPT team in 2011 as a Microbiologist.  He has performed testing and accumulated knowledge in a multitude of areas including Organism Identification, Microbial Limits Testing, Anti-Microbial Effectiveness Testing, Sterility Testing, and Particulate Matter Testing.  He currently is a Group Leader III in the Sterility testing group and oversees Particulate Matter testing as well as Routine Sterility Testing.  In this role he assists clients in designing their testing to meet compendial requirements and supports the design, planning, and execution of ongoing testing needs and requirements of clients, using his knowledge and expertise to ensure the client’s needs are met in a timely manner and per all regulatory requirements.  Zachary earned his BS in Microbiology from York College of Pennsylvania.

Dr. Anthony Blaszczyk is in the Pipeline Development group within USP’s Global Biologics department. At USP, he works with scientific experts and stakeholders to develop new standards to support biopharmaceutical quality assessment and development. Prior to USP, Anthony worked at Catalent Cell and Gene Therapy, where he managed an analytical development team responsible for the development, qualification and transfer of methods. He obtained his Ph.D. in Biochemistry from Penn State University in 2018.

Elizabeth Brockson is an Aseptic Processing and Sterility Assurance Lead in Global Sterility Assurance and Microbiology at Takeda and is based out of Minneapolis, MN. Liz has a background in benchtop microbiology and immunology, as well as over 10 years of experience in FDA-regulated businesses as a quality assurance and quality control technical professional. In her current role, Liz is responsible for leading the design and implementation of Takeda's global manufacturing sterility assurance program. Liz holds a Bachelor’s degree in Animal Sciences and a Master’s degree in Public Health, both from The Ohio State University.

Jennifer Cheung brings 27 years of quality, compliance and regulatory experience in biotechnology and pharmaceutical manufacturing prior to joining WuXi Advanced Therapies, a contract testing, development, and manufacturing organization (CTDMO) in 2020. In her current role, she is supporting many cell and gene therapy clients by interpreting and applying the phase appropriate GMP regulations and requirements to accelerate development and manufacturing timeline, focusing on client satisfaction and the right first-time performance. She is passionate in promoting GMP convergence, inspection reliance, and data driven, risk-based decision-making to maximize patients’ benefit. Jennifer held various leadership positions in United States and Singapore, spent five years on a biologics parenteral manufacturing startup project and three years to expand the biologics drug substance site overseas. Jennifer has a BS degree in Microbiology and MS degree in Manufacturing Management.

Sara Cook is an accomplished professional known for her expertise in leadership, data strategy, data governance, data science, advanced analytics, and statistics. She excels in strategic planning, creative problem-solving, and fostering cross-collaboration in Science, Technology, and Manufacturing.

With a distinguished career, Sara has crafted and executed strategies to address critical business challenges, utilizing design thinking and comprehensive data programs. She has established Data and Analytics Center of Excellence, leveraging new digital capabilities like data science, ML, AI, and automation to drive impactful business value.

In the domain of CMC statistics, Sara has been a vital advisor in biotech and pharma, where she enhances product quality through optimization of processes, assays, and formulations. Sara adeptly turns big data into valuable insights and applies methodologies like QbD and statistical process control.

Sara possesses a Doctorate, Master's, and Bachelor's in Chemical Engineering. Her achievements have been recognized through various honors and awards, underscoring her dedication and expertise.

With roles at ILIACOOK STATISTICAL CONSULTING, PHARMEFEX, and NOVAVAX, Sara has made significant contributions to our industry. Her insights and expertise are poised to address regulatory and quality aspects, making her a valuable speaker for conferences focused on the application of AI in biotech and pharma.

Sergio Diaz is the PKM Product Marketing Manager. He is responsible for capturing market needs, influencing product strategy, and supporting product development.

During his 20+ years career at Emerson, Sergio has held different roles servicing multiple industries including Life Sciences. Sergio's previous roles included Field Service Engineer, Test Engineer, Project Engineer, and DeltaV product marketing manager.

Sergio holds a BSc and an MSc in Electrical Engineering from the National Polytechnic Institute in Mexico.

Margaret Faul, PhD, Vice President, Manufacturing and Clinical Supply, Amgen Inc.

Beth Fulton is a consultant with ValSource. She is an expert innovator in the development and implementation of quality systems and quality risk management (QRM) for pharmaceutical, biopharmaceutical, cell therapy, and combination products. She has a BS in food science from Cornell University, an MS in Zoology from University of New Hampshire, and an MS in Food Science and Human Nutrition from the University of Maine. She can be reached at [email protected].

Patrick Gavit has over 35 years of experience in the biotech arena encompassing roles in both the biologics and plasma industries. In his most recent role, he is the Head of Manufacturing Sciences at Takeda’s Los Angeles manufacturing facility. In this role he manages a technical team of 50 people who are responsible for ensuring the manufacturing processes run smoothly and for making improvements to the processes. Patrick has experience in process development, technology transfer, and continuous improvement principles. He is Six Sigma Blackbelt certified. Patrick has worked with several community colleges to develop a Biotech curriculum that includes a certification process. He promotes careers in Biotech by speaking at local universities and colleges.

Ghada Haddad is currently an Executive Director, leading the Global Quality Transformation and Regulatory Intelligence Organization at Merck & Co. Prior to that she led the Global cGMP and Compliance Auditing Organization. She held several leadership positions such as the Head of the Global Quality Risk Management Center of Excellence, building a team of experts to develop and implement a robust and sustainable QRM program. She holds a chemistry degree, an MBA, and a PhD in Regulatory Sciences. She has over 24 years of experience, working in the Biotech and Pharmaceutical industries in the areas of Quality Risk Management (QRM), Validation, Quality Systems and Regulatory, including research, management (people and projects), process development, auditing, regulatory agency inspection, change control and validation. Haddad was the chair of the PDA Paradigm Change in Manufacturing (PCMO) initiative, co-chaired the Aging Facilities Points to Consider, co-chaired the PDA Annual meeting, a previous member of the Science Advisory Board, and the PDA Board of Directors.

Richard Horgan is the Founder and President of Cure Rare Disease. He has a deep passion for reimagining how rare and ultra-rare diseases are treated. With a younger sibling impacted by a rare disease, Rich has a strong interest in developing life-saving treatments for ultra-rare diseases. He formed an interdisciplinary collaboration of world-class researchers and clinicians to pioneer the development of therapies for rare, genetic diseases. Prior to making his foray into biotech, Rich had extensive experience working in new business development at Corning Incorporated where he led the successful launch of a new product line. He also launched a successful car washing business in New York. He holds a BS from Cornell University where he graduated summa cum laude and an MBA from Harvard Business School where he was awarded the Blavatnik Fellowship for Life Science Entrepreneurship. Rich was recognized by Business Insider as one of ‘30 leaders under 40 transforming healthcare in 2020’ and, most recently, was named on the 2021 Forbes 30 under 30 list.

Stephanie Lee is a CMC Project Manager in Process Development at Amgen, a company committed to delivering medicine to “every patient, every time”. She manages global cross-functional teams, programs, and projects that support lifecycle management, design controls for combination products, and clinical/commercial development across multiple therapeutic areas. Stephanie holds a Master of Business and Science degree from Keck Graduate Institute, a Bachelor of Science in Biology from the University of California, Los Angeles (UCLA), and a certificate in Bioscience Industry Law and Practice from Southwestern Law School. Previously, she has worked at Stanford Health Care, which furthered her interest and commitment to patient health and well-being.

Stephanie has been an active leader and volunteer in the PDA West Coast Chapter (WCC) and Southern California (SoCal) Chapter since 2019, serving as the current PDA West Coast Chapter President and former PDA SoCal Student Chapter President. She is also on the PDA Annual Program Planning Steering Committee. Stephanie was previously selected for the 2022 PDA Early Career Professional (ECP) Mentorship Program, where she created the PDA Guidebook for the global and local chapters, and received the 2022 PDA Outstanding Early Career Professional Award.

Highly skilled and detail-oriented data integrity subject matter expert with 30 years of experience ensuring data accuracy, reliability, and security.

His publications include two books on Computer Systems Validation, which can be found at https://www.routledge.com/authors/i8734-orlando-lopez.

His online profile can be found at https://www.linkedin.com/in/orlandolopezrodriguez/

Peter has over 18 years of experience in pharmaceutical and biopharmaceutical industries. Peter held various roles within industry, primarily around process solutions and engineering for drug substance facilities. He has extensive knowledge of bioprocess manufacturing and helped design new facilities and retrofit existing facilities. Peter joined G-CON Manufacturing in 2016 where he now consults with clients in the design of their cGMP facilities utilizing G-CON’s pre-fabricated autonomous clean rooms by capitalizing on his process and regulatory know how.

Peter received his Bachelor of Science in Chemical Engineering and a Minor in Biomedical Engineering from Cornell University. He received is M. Eng in Chemical Engineering from Cornell University. He is also very active within the PDA where he currently sits on the PDA BioAB, co-Leads the Biopharmaceutical Manufacturing IG, and Mobile Manufacturing Task Force.

Kate Malachowski is an Associate Director of Manufacturing Science and Technology (MS&T) at Novavax. In this role, she leads a team of scientists and engineers to support Novavax's global drug substance manufacturing operations, data trending, and CPV programs. She has also previously worked at Catalent supporting gene therapy projects and with the BioPhorum Extractables and Leachables work group. Kate previously served on the 2023 PDA Annual Meeting Planning Committee. Before entering the biotech space, she worked in microscale medical and semiconductor devices at the Army Research Laboratory and Northrop Grumman. Kate holds a bachelor's degree in Chemical Engineering from Virginia Tech and a PhD in Chemical and Biomolecular Engineering from The Johns Hopkins University.

Ira Mann, President of IQ Referrals & BioQuality Referrals has been helping industry members find their passions and advance their careers for over 20 years. Starting out in compliance and auditing and pivoting to creating impactful career matches for others while building long-term relationships with influential industry leaders, Ira has unique insights into our industry and significant success in preparing individuals and companies for their future.

Over the years, Ira built a sterling reputation directing Referral-based searches for Quality, TechOps, Engineering, Scientific, and Regulatory leaders in Life Sciences and determined:

• Clients would benefit and he'd have a stronger command of the passive candidate marketplace by working via referral vs the internet pool others search.
• By specializing in select niches and working with professionals because they excel (and not because they are "looking"), he'd represent a higher quality network and create more impactful matches.
• A superior level of client service can be provided by only accepting searches when there is confidence they can be successfully and efficiently managed.

Juha Mattila is Director of Sterilization Technologies for STERIS Corporation Life Sciences Division, a leading provider of infection prevention and contamination control products and services. Mr. Mattila has been with STERIS Corporation since 2000 with experience in the Life Sciences equipment solutions for pharmaceutical/biopharmaceutical/ATMP production, medical devices, high containment, and laboratory research industries. He is responsible for a GMP products portfolio including Vaporized Hydrogen Peroxide (VHP) Vacuum Sterilizers and VHP Atmospheric Pass-through Chambers, cGMP Component and Terminal Steam Sterilizers, and Critical GMP Utility Equipment (WFI Distillation and Pure Steam Generators). He is a presenter and trainer at national and international conferences including The Parental Drug Association (PDA), International Society of Pharmaceutical Engineers (ISPE), and Universal Prefilled Syringe conferences, amongst others. He currently participates in several ISO and CEN standards working groups including EN 17180 – VH2O2 sterilizer equipment standard, ISO 22441 - VH2O2 process standard, ISO/AWI 19253 – Steam sterilizer equipment standard for liquid load sterilizers, Finland SFS hospital instruments management systems standard, and contributed to AAMI TIR 17 and EU Annex 1 reviews.

Amanda McFarland is a quality risk management and microbiology senior consultant with ValSource, Inc. She specializes in the creation and implementation of risk management programs and developing risk-based strategies for use in clinical and commercial settings. Amanda is an active member of the Parenteral Drug Association (PDA), co-chair of the PDA ANSI standard on QRM in aseptic processing, a member of the PDA Regulatory Affairs and Quality Advisory Board, an instructor at PDA -TRI on quality risk management and a member of the Kilmer Regulatory Innovation team. She has a BS in entomology and an MS in mycology, both from the University of Florida. She can be contacted at [email protected].

Matthew McGann is a leading expert in analytical technologies used for the characterization and production of pharmaceutical and biopharmaceutical drugs with over 17 years industry experience. His particular focus is in methods and technologies used for the detection and characterization of particulates including image analysis methods and other optical methods, as well as applications of Artificial Intelligence, and Machine Learning to these technologies. With a Master of Science from the University of Sydney, he has worked with multiple industry startups as well as industry leading technology companies to bring new and disruptive technologies to the market for the characterization of pharmaceutical and biopharmaceutical products to improve drug safety and efficacy.

Melanie McIntosh is a Senior Quality Assurance Specialist with PharmEng Technology and has 18 years of experience in quality control and quality assurance. She has a BSc in Chemistry and a BA in English. She has worked in ISO and FDA regulated chemical, food, and pharmaceutical laboratory and manufacturing facilities. She is experienced in initiating and closing change controls, deviations, and CAPAs. She has provided raw material, in-process, and finished product testing approval and batch record review and approval. Her other skills include writing SOPs; writing and executing IQ/OQ/PQs; quality auditing; gap analysis; risk management; complaint management; and materials management. She has three certifications from ASQ: Certified Quality Engineer, Certified Quality Auditor, and Certified Six Sigma Green Belt. She is a member of the ISPE CaSA Chapter Outreach Committee. She is the secretary of Toastmasters of West Georgia.

20 years experience in both clinical trial and commercial manufacturing of small molecule and biotech DS molecules.

A licensed EU Qualified Person (2008).

Ryan Murray is a quality and manufacturing science Senior Consultant with ValSource, Inc. He is primarily focused in the areas of quality and regulatory compliance, facility design and control, technology transfer, process qualification, and aseptic risk management of both biologics and advanced therapy medicinal products (ATMPs). Ryan is an active member of the Parenteral Drug Association’s Texas Chapter and the International Society for Pharmaceutical Engineering (ISPE). He has a BS in biomedical science and MS in biochemistry and biophysics from Texas A&M University.

Antonio Ortiz has over 18 years of experience in the pharmaceutical industry in research and development, technical transfer, process and cleaning validation, regulatory submissions, and Good Manufacturing Practices (GMP) manufacturing troubleshooting and investigations. He holds a master’s degree in biomedical engineering and a bachelor’s degree in chemical engineering.

Prior to joining STERIS Life Sciences, Antonio spent time at Stryker, Bausch + Lomb, Catalent and Apotex in positions including R&D Process Engineer, Validation Engineer, Process Engineer and Technical Services Scientist.

Antonio provides technical support to STERIS Life Sciences Customers by integrating multiple areas of specialization to resolve complex pharmaceutical and biopharmaceutical challenges. He also administers global pharmaceutical and biopharmaceutical industry education programs and presents at industry conferences.

Antonio is an active member of the International Society for Pharmaceutical Engineering (ISPE) and the Parenteral Drug Association (PDA).

 

Ken Paddock is a Quality Sterility Assurance Director at Baxter Healthcare. Ken is responsible for leading a global team of Regional Sterility Assurance Representatives to create and carry out a unified SA strategy plan across Baxter as the Global Sterility Assurance (SA) Lead within the quality department. The team is also responsible for regional sterility assurance compliance and offers quality management for facility-level microbiological control and cleanroom practices. Ken has more than 25 years of experience in the pharmaceutical sector, with expertise in environmental monitoring systems, product/process development, and terminal sterilization (ethylene oxide, moist heat, and radiation) for both drug and device product.

Ken is a current member of the PDA Chapter Board and has served the chapter in a number of elected capacities since 2010. These include President, President-elect, Treasurer, Secretary and Member-at-Large. In addition, he serves on the PDA's Science Advisory Board, a diverse group of leading bio-pharmaceutical industry experts setting strategic direction for the PDA on technical topics associated with pharmaceutical manufacturing and quality. He also serves as the co-chair for the 2023 and 2024 PDA Annual Meetings.

Malav Parikh is the Director of QRM in Takeda’s global Quality Compliance and Systems function. In his current global role, Malav is focused on implementing a harmonized and sustainable QRM program embedded within the Quality Management System, including the creation of risk management procedures, tools, training, and workflows as well as consultation for risk-based strategies and assessments. Malav has a graduate degree in mechanical engineering and has had the privilege of being involved in various areas within the pharmaceutical, biotech, and medical device domains including new product introduction, supplier management, quality engineering, process validation, quality compliance/systems, and quality analytics. Malav is an active member of the PDA and is currently the co-lead for the PDA Quality Risk Management Interest Group (IG).

Mr. Divyang Patel has broad experience spanning pharmaceuticals, computer systems validation (CSV), equipment qualification, QA/QC, project management, technical and quality analysis, and R&D. Divyang earned an Honours BSc in Molecular Genetics and Microbiology from the University of Toronto and a Certification in Project Management from Mitacs. He is fluent in English, Gujarati, and Hindi, and is currently learning French. Presently, Divyang is a member of AtkinsRealis' Consulting team for the Life Sciences Market, serves as a Committee Member for PDA Canada, sits on the Program Committee for the 2024 PDA Annual Meeting, and is an Abstract Reviewer for the Annual Meeting’s Science Track Sub-Committee.

Julian started his career in the pharma industry as a project manager at a German fill & finish system supplier.

After a short time in the semiconductor business, Julian returned to the pharmaceutical fill & finish business as a Sales Director at groninger responsible for the DACH market. Now leading Business Development and Product Management, Julian is passionately focused on emerging and future technologies to meet the requirements of the vastly changing pharma industry.

Julian is an active member of PDA (EU Co-Leader for the Sterile Processing Interest Group, PtC Aseptic Fill and Finish, PtC RABS) and ISPE.

Josh Russell has been involved in designing and implementing new and innovative technologies within the biopharmaceutical and cell & gene industries for more than 15 years. His primary interest and focus has been drug product manufacturing facilities and sterile products processing. After earning his Bachelor of Science in Mechanical Engineering from St. Martin’s University, early in his career Josh designed complex industrial machinery and systems for a variety of industries including aerospace, hygiene and life sciences. He quickly grew a passion for developing solutions that address the emerging challenges brought on by the biopharma industry’s shift toward more personalized patient-specific therapies. While at AST, he led technical teams that ultimately developed now widely used adaptive robotic systems in aseptic applications used in sterile injectable product manufacturing.

Mr. Ankur K. Shah, is a Lead Process Engineer at Arcadis-DPS Group with over 15 years of experience in facility design and construction. His experience includes cell and gene therapy facilities, and oligonucleotide-based therapeutics manufacturing facilities. His expertise extends in executing scoping studies through construction in Process Engineering and Project Engineering roles.

Mr. Shah has recently presented at ISPE FOF 2023, ISPE Aseptic 2023 and PDA Annual 2022 and has published a variety of articles.

Mr. Shah holds a Masters in Chemical and Biomolecular Engineering from the University of Pennsylvania and a Bachelors in Chemical Engineering from the Indian Institute of Technology, Bombay, India.

Sebastian Teitz graduated from University of Cologne with a diploma in Genomic Imprinting. He followed this with a PhD in the Analysis of O-glycosylated Proteins. Sebastian has previously worked at Fred Hutchinson Cancer Research Center (Seattle, WA), looking into Cytomegalovirus and its Role in Graft vs. Host Disease and Transplant Rejection; and at NewLab BioQuality / Charles River as the Project Manager of Virus Clearance Studies. Within Asahi his focus is on virus- & pathogen safety, supporting customers & internal entities technically and scientifically, and being liaison for authorities, CROs and industry consortiums of the biopharmaceuticals industry.

At Biopharma-Excellence he is now consulting developers of new drugs in scientific- & regulatory affairs during all stages to market access.