Roanoke , VA , United States
Provide technical guidance and development of staff in the Analytical Development and Characterization group. Strategic Planning of resources to address methods development and characterization needs throughout the drug development cycle, and active participation on project teams
Lead a group of scientists and associates responsible for assay development and characterization of the facility recombinant antibodies and antibody drug conjugate therapeutics. Work on and regulatory filings to US and EU agencies by performing phase appropriate characterization experiments and writing and reviewing of the analytical and characterization sections of INDs, BLAs, and NDAs - Presentations to management as well as report writing and reviewing.
Initiate and drive special projects such as the acquisition of new capital equipment and the establishment of new analytical techniques, and the application of industry best-practices to reduce drug development cycle times and costs.
REQUIREMENTS: - Minimum of 7-10 years experience in analytical development in the biotechnology industry, is required - Proven managerial skills and at least five years direct supervisory experience are essential - Extensive experience with the implementation of advanced analytical methods and biophysical characterization tools like HPLC, capillary electrophoresis, mass spectrometry and spectroscopy - Experience with therapeutic protein characterization for BLA filing is highly desired. - Intimate knowledge of FDA and ICH guidance and industry standards is expected - Excellent analytical skills, oral and written communication skills, as well as a demonstrated ability to operate both independently and in cross-functional team settings, are essential
• EDUCATION: A PhD in analytical chemistry