Fawcett, Gochnour, Guldager Awarded Prestigious Industry Credential

Fawcett, Gochnour, and Guldager are three of 17 professionals to be awarded this new certification and were assessed through demonstrated education, industry experience, and a rigorous examination. The credential offers the first competency-based international certification for pharmaceutical professionals. It represents a global standard and covers a range of competencies from drug product development through manufacturing.

The CPIP certification can unlock greater career opportunities and provide a career development pathway for pharmaceutical professionals. It also provides industry-wide recognition of accumulated experience, while giving employers and suppliers a competitive advantage by ensuring that their professionals have diverse knowledge and skills that are certified to a global competency standard.

Niels Guldager has been an ISPE Member since 2000. He has 15 years of experience with biotech and pharmaceutical processes, including both operational experience as production engineer in large-scale biopharmaceutical production for both upstream and downstream process steps, and project experience as front-end study leader, process lead, and process engineer. His project focus is process and technology in front-end activities such as feasibility studies, conceptual briefs and conceptual designs. Recent projects include early design and consulting roles in projects for MAb-production facilities, vaccine facilities, and multi-product facilities. Guldager is currently engaged in single-use technology community work for ISPE and PDA. He holds a MSc in Chemical Engineering from the Technical University of Denmark.

Scott Gochnour has been an ISPE Member since 1993. He has more than 20 years of experience in formulation and process development, equipment design and qualification, materials selection and evaluation, and scale-up/validation for commercial operations. He has been with Watson Pharmaceuticals for 20 years in various engineering and management positions in Research & Development and Production Operations and is currently responsible for the formulation research, development and manufacturing of clinical supplies for topical and transdermal products. He graduated from the University of Utah with a Bachelor of Science degree in Materials Science and Engineering with emphasis in Biomaterials. He is also a vice chairman of the board for the Intermountain Biomedical Association.

David Fawcett has been an ISPE Member since 1996. He has more than 19 years of experience in the pharmaceutical industry and founded PEC A/S (Pharmaceutical Engineering Consultants) in Denmark in 1998. At PEC, he has had the opportunity to assist such companies as Biogen Idec, CMC Biologics, Ferring Pharmaceuticals, GlaxoSmithKline, ALK Abelló, and Novo Nordisk with project management and validation services. Fawcett began his career as a project engineer with GlaxoSmithkline in England, where he was responsible for the specification, design, installation and validation of a wide range of equipment and processes such as solvation of inhalation APIs, utensil washers, isolators; special purpose assembly equipment; and sterile syringe filling machines. Fawcett holds a Bachelor of Engineering degree in Chemical and Process Engineering from the University of Newcastle-upon-Tyne, England.