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The GMP Laboratories business unit of PPD is a market leader in providing GMP analytical services to the Pharmaceutical, Biotechnology, and Medical Device industries. The PPD GMP Laboratories business has employees located in laboratories in Middleton, Wisconsin and Athlone, Ireland. PPD GMP Laboratories is currently seeking a Director of Analytical Method Development and validation (AMDV), to be based in our Middleton, Wisconsin facility. This is an exciting opportunity to join a rapidly growing scientific service business within one of the world’s premier drug development companies. The Director will oversee of team of 75 employees, and will be responsible for all financial, operational and technical activities involved in delivering quality biopharmaceutical testing services to our clients.
We seek a highly collaborative, motivated and innovative candidate with demonstrated expertise to provide scientific and technological leadership in biophysical/analytical characterization to enable and support biologics drug development for large molecules. Key responsibilities include, management of a team focused on characterization of monoclonal and multi-specifics antibodies, antibody drug conjugates (ADC) and other protein therapeutics using state-of-art technology. Provide creative approaches to support client’s comparability protocols to drive the process characterization and/or process qualification studies.
Education and Experience:
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years) or equivalent and relevant combination of education, training, & experience
PhD, preferred qualifications include a graduate degree in protein chemistry, molecular biology, virology, or related discipline, as well as at least 10 years of leadership experience in the cGMP biotechnology industry
5+ years of management responsibility
Preferred qualifications include a graduate degree in protein chemistry, molecular biology, virology, or related discipline, as well as at least 10 years of leadership experience in the cGMP biotechnology industry
Business education and/or experience is a plus.
Technical and Management Experience