Llurellyn Malcolm

Llurellyn Malcolm, Principal Scientist, Pfizer Inc.

Llurellyn Malcolm is currently employed at Pfizer Pharmaceutical Inc. as a Principal Scientist at the Pearl River site in New York.

He joined Pfizer Inc. in 2000 providing analytical support within the Product and Process Development group in Brooklyn, New York. In 2004 he joined the analytical team at the Morris Plain site, New Jersey to support new technology development projects and pilot plant operations. Focus areas entailed FT-IR and NIR spectroscopy, NIR chemical mapping and imaging applications linked to product quality and design. Major activities involved utilizing material characterization tools (e.g. spectroscopy, differential scanning calorimetry and particle size distribution) in the investigation and troubleshooting of API, excipients and oral solid drug products.

Within the past five years, Llurellyn has shifted his focus area to supporting the development of science based approaches to stability studies within a commercial space. This involves utilizing the Accelerated Stability Assessment Program (ASAP) as root cause investigative and risk assessment tool. Other areas of application Llurellyn has explored using the statistical methodology include supporting drug product packaging design, excursion studies and gaining an improved understanding of product stability with respect to ICH storage conditions.

Llurellyn holds a B.S. in Forensics Science from John Jay College, a M.S. in Pharmaceutical Chemistry from Lehigh University. Llurellyn is also an affiliate of the American Association of Pharmaceutical Scientist (AAPS).