Ask The Experts

Cell & Gene Therapy

Jennifer A. Head, Ph.D.

Manager of Regulatory Affairs, Microbial Manufacturing Services (MMS)

Dr. Head provides expertise and Regulatory Strategy in Cell and Gene Therapy CMC. She also has experience in the regulatory support of controlled substances, new molecular entities, new chemical entities, and biological products. She has worked within CMOs, CROs, and pharma with an emphasis in regulatory activities for investigational new drug applications (IND), new drug applications (NDA), and biologics licensing applications (BLA). This experience includes, but is not limited to, providing technical support, regulatory strategy, regulatory intelligence, interpretation of regulatory guidance, and drafting and reviewing of CMC documents and regulatory submissions. She has experience with interacting with regulatory authorities and possesses an academic background in vaccine development and medical technology.
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Clinical Trial Services

Harry Berlanga BSc(Hons) MSc CBiol MSB

Senior Director, Quality, EMEA

A Chartered biologist, with a Masters in Pharmaceutical Sciences, Harry has over 20 years’ industry experience in Steriles, Biologics & Solid Dose in both Commercial and Clinical Manufacturing and Packaging. Harry currently holds the position of Senior Director, Quality, EMEA, leading the EMEA Quality function across the Clinical Trials Division at Thermo Fisher Scientific. Based in Horsham, UK, Harry oversees 6 sites specializing in the Manufacture, Packaging and Distribution of Investigational Medicinal Products (IMPs). Harry previously led Quality at the Thermo Fisher Scientific Horsham site for several years. Harry is an experienced Qualified Person (QP) for clinical and commercial products.
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Monica Commerford, Ph.D.
Viral Vector Services

Monica Commerford, Ph.D.

Head of Viral Vector Services Regulatory Affairs

Monica is an expert in sterility assurance for investigational new drug applications and biologics licensing applications (BLA). She frequently interacts with regulatory authorities, providing guidance and compliance oversight. Highly skilled in microbial control, product quality microbiology, regulatory intelligence, and interpreting regulatory guidance, Monica previously worked at the FDA as a product quality microbiology and BLA reviewer.
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Mike Cruskie
API (Small Molecule)

Michael Cruskie, Ph.D.

Senior Director and General Manager

Dr. Cruskie has more than 25 years of experience working with small molecule APIs, ushering them from early development to scale-up and commercial manufacture. His areas of expertise include supply chain management, technology transfers, project management and business development. He leads a team of over four hundred colleagues at our manufacturing sites in Florence, SC.
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Christy Eatmon
Steriles

Christy Eatmon

Senior Staff Scientist, Research & Development

Christy Eatmon provides technical support, designs strategies, and supports new business opportunities for our sterile manufacturing business. Christy has more than 14 years of experience in pharma with an emphasis on process engineering, product development, aseptic manufacturing and filling. She has working knowledge of all phases from drug discovery to sterile product commercial manufacturing with expertise in small and large molecule sterile formulation. Previously, Christy supported our Greenville, NC, site as a Senior Principal Scientist.
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Doug Hausner
Commercial Manufacturing

Douglas Hausner, Ph.D.

Senior Manager, Continuous Manufacturing

Douglas works with our commercial organization as the technical sales leader for continuous manufacturing, and is highly skilled in process analytical technology and business development. He is a member of the International Society for Pharmaceutical Engineering’s community of practice on continuous manufacturing and on the United States Pharmacopeia expert panel on continuous manufacturing.
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Jeff Hou
Biologics (Large Molecule)

Jeff Hou, Ph.D.

Director, Process Development

Jeff is the site head for biologics at our site in Princeton, NJ. He leads technology innovation and new technology implementation, engaging the Thermo Fisher Scientific ecosystem to further develop new innovations. Jeff is highly skilled in biologics and cell line development, tech transfers, GMP manufacturing, cell biology, lead candidate discovery and process development.
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Gordon Hutton, Ph.D.
API (Small Molecule)

Gordon Hutton, Ph.D.

Materials Science Lead

Gordon’s career spans over twenty-six years in the pharmaceutical industry with high level experience of organic chemistry, API development and commercial manufacturing. He is highly skilled in crystallization processes for commercial applications, and leads a team of materials scientists on complex projects while working across drug product and drug substance boundaries.
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Mathew Jones
API (Small Molecule)

Matthew Jones, Ph.D.

Senior Manager, Crystallization

Matthew is the head of crystallization at our site in Linz, Austria, and provides consulting and support of our API sites in Regensburg, Germany and Greenville, SC. He is highly knowledgeable in solid state chemistry and crystallization process development with over twelve years of experience in the pharmaceutical industry.
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Anil Kane
Formulation & Development

Anil Kane, Ph.D., MBA

Senior Director, Global Technical and Scientific Affairs

Dr. Kane has more than 25 years of experience in the science and business of taking molecules through the entire drug development process. His extensive knowledge spans early stage development to scale-up and commercial manufacturing, and includes technology transfers between global sites and life cycle management.
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Kevin Kane
Commercial Manufacturing

Kevin Kane, Ph.D.

Senior Staff Scientist, R&D

Kevin has over twenty-five years of experience in synthesis, process chemistry, drug delivery, formulation and manufacturing for discovery through commercialization. He is highly skilled in enabling technologies including spray drying and hot melt extrusion techniques for poorly soluble molecules, as well as in oral modified release and injectable drug delivery methods including matrix tablets and powder-filled vials.
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Sanjay Konagurthu
Formulation & Development

Sanjay Konagurthu, Ph.D.

Senior Director, Science and Innovation

Dr. Konagurthu has more than 22 years of experience managing and assisting in the development of compounds from discovery through clinical and commercial manufacturing. He has extensive experience in oral solid dosage forms and solubility enhancement techniques such as spray-drying, hot-melt extrusion, size-reduction, lipid-based systems and complexation. Sanjay is an expert in in designing novel drug delivery systems and process development and scale-up techniques including technology transfers.
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Keirnan LaMarche, Ph.D.
Oral Solid Dose

Keirnan LaMarche, Ph.D.

Senior Staff R&D Manufacturing Scientist

Keirnan leads a cross-disciplinary team of scientists for rapid product development on Thermo Fisher Scientific’s continuous manufacturing platform. His expertise includes solid dosage form design, powder flow and tablet compaction. Keirnan has developed a novel physical model-based method for determining material compaction properties, and is highly skilled in characterized and model drying processes and unit operators.
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Jason Mieding
Logistics

Jason Mieding

Senior Director, Logistics

Jason leads our global transportation business with multiple service offerings including cold chain and packaging solutions, as well as customs and regulatory guidance. He is highly experienced in supply chain with a focus on sales and operations planning, transportation and logistics management, and system enhancements including SAP. Jason is certified in production and inventory management by the American Production and Inventory Control Society.
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Ronald Perry
Softgels

Ronald Perry

Senior Manager, R&D

Ron leads the R&D team at our site in High Point, NC, managing softgels development and technical transfers for investigational new drugs, abbreviated and new drug applications, over-the-counter, and monograph products. Ron is a Registered Pharmacist and is Immunization Certified, with over nineteen years of small molecule oral solid dosage and process development experience.
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Peter Poechlauer
API (Small Molecule)

Peter Poechlauer, Ph.D.

Innovation Manager, Small Molecule API

Dr. Poechlauer possesses more than thirty-five years of experience in biocatalysis and oxidation chemistry. He is an expert in the application of innovative technologies, such as process intensification and microreactor flow chemistry, to small molecule API process development.
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Frank Ritacco - Biologics Development & Manufacturing Expert
Biologics (Large Molecule)

Frank Ritacco, Ph.D.

Director, Scientific and Technical Affairs

Frank has a PhD in Microbiology and Molecular Genetics from Rutgers University, and 20+ years of experience in the pharma industry. Areas of expertise include mammalian cell culture, microbial fermentation, cell line development, media development and optimization, process development, scale-up, tech transfer, and clinical manufacturing. Frank oversees new technology development in the Bioprocess and manufacturing sciences, driving scientific innovation and collaboration, and serves as a technical subject matter expert, interfacing with customers and the biopharma community.
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Richard Snyder
Viral Vector Services

Richard Snyder, Ph.D.

Vice President, Science and Technology

Richard leads the viral vector services science and technology team’s company wide initiative developing multi-generational manufacturing and analytical platforms, used for the GMP production of viral vectors for in vivo human gene therapies and ex vivo modified-cell based therapies. He is highly skilled in viral vector mediated gene transfer and development of novel viral vector-based human gene therapies. Richard was presented with the “Innovator of the Year” award by the University of Florida’s UF Innovate research institution in 2020.
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Kasper van den Dries
Softgels

Kaspar van den Dries, Ph.D.

Senior Director Science and Innovation, Softgels

Dr. van den Dries is the head of research and development for softgels, leading the development teams at our High Point, NC, and Tilburg, Netherlands, sites. He has over twenty years of experience in pharmaceutical research and development with experience in solid dose formulation, technology transfer and regulatory filings.
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Contact us today to utilize our network of API and biologics experts for your upcoming development or commercial project.