Director Biological Manufacturing and Clinical Supply Management
- Expired: May 07, 2020. Applications are no longer accepted.
Company ProfileInovio is an innovative biotechnology company focused on the discovery, development, and commercialization of its synthetic DNA technology targeted against cancers and infectious diseases. Inovio's proprietary technology has been demonstrated to consistently activate robust and fully functional T cell and antibody responses against targeted cancers and pathogens. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline.
Partners and collaborators include AstraZeneca, Regeneron, Roche/Genentech, ApolloBio Corporation, GeneOne Life Science, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency, National Institutes of Health, National Institute of Allergy and Infectious Diseases, National Cancer Institute, HIV Vaccines Trial Network, Walter Reed Army Institute of Research, Medical CBRN Defense Consortium (MCDC), The... Wistar Institute, and the University of Pennsylvania. For more information, visit www.inovio.com.
*Notice to Applicants: Inovio is looking for an Associate Director, a Director or Senior Director Biological Manufacturing and Clinical Supply Management. We will be making the decision on level based on years of experience and level of autonomy. The successful candidate will be hired at the level commensurate with the education, knowledge, skills, and experience required.
While the basic functions will be the same if we select an Associate Director based on their skill set he/she would receive more day to day guidance.Job summaryThe Director, Biological Manufacturing and Clinical Supply Management will be responsible for oversight of all clinical supplies management and all manufacturing outsourcing to support multiple parallel clinical trials of DNA plasmid vaccines. The director will develop and maintain an overall manufacturing/clinical supply strategy from DNA fermentation to vaccine release and distribution to preclinical testing facilities as well as clinical sites for the conduct of Phase I-III clinical trials in a biopharmaceutical company. Significant leadership skills will be required to oversee potentially multiple contract manufacturing organizations (CMO) as well as vendors for the release testing and distribution of both active and placebo products.
The director will be responsible for ensuring all outsourced manufacturing and clinical supplies activities are performed under cGMP or GLP where appropriate. The candidate will be responsible for authorship of all clinical supply and manufacturing related regulatory submissions and query responses for submission to global regulatory agencies. This responsibility will require a thorough knowledge of the relevant regulatory requirements and guidances that relate to clinical supplies management and biologics manufacturing and control to ensure compliance with all international regulatory requirements.The successful candidate will be expected to present his or her manufacturing strategy to senior management and plan and ultimately execute on the agreed upon final strategy.
Experience with the DNA delivery / DNA vaccine fields is required.Essential job functions and duties Provide high level biologics manufacturing control and clinical supplies management advice, identify regulatory requirements and recommend manufacturing strategy for international vaccine and immunotherapy development. Participate in Management Committee (MC) to ensure continuous MCSM support of development projects. Communicate complex and potentially complicated manufacturing issues and provide strategic and/or tactical recommendations to senior management.
Participate on project teams and direct activities to ensure integration of MCSM needs and requirements in pre-clinical, clinical plans as well as planning for commercialization Assess scientific data for the purposes of evaluating manufacturing issues to develop recommen
AddressPlymouth Meeting, PA
HealthcareView all jobs at Inovio Pharmaceuticals