Senior Director, PDP
Posted on Apr 5, 2021 by Emergent BioSolutions
The Sr. Director, Process Development and Production (PDP) will be responsible for process development, clinical trial material production, and technology transfer to the commercial manufacturing site. This position will be involved in Emergent's various viral, virus-like-particle (VLP) and nanoparticle vaccine development programs, which includes cell culture, viral amplification/VLP transient transfection, chromatography purification and diafiltration/ultrafiltration processes. This position will manage several teams upstream process development, downstream process development, manufacturing engineering, cell line development, assay development and clinical production teams to efficiently complete the vaccine process development and clinical production work. Additionally, this role will support IND and BLA CMC sections and all internal and external audits.
Reasonable accomOrganizationations will be made to enable individuals with disabilities to perform the essential functions.
Successfully manage and direct the activities of the Process Development & Production group.
Provide leadership and technical expertise in support of vaccine development and clinical production.
Mentor and support the professional development of team members.
Lead cross-functional teams and coordinate with Analytical Development, Product Development, Quality Assurance and Project Management teams, in an effort to complete the development and clinical production work efficiently.
Responsible for PDP planning, and multi-year resource forecast.
Lead cGMP activities (facilities, personnel, equipment, processes, and procedures) compliant and efficient.
Write and review investigational new drug (IND) and BLA CMC section.
Evaluate and manage CMO/vendor activities.
Support internal and external audits.
Support FDA and EMA agency related meetings.
Minimum Education, Experience and Skills
Minimum of 15 years relevant industry experience with an M.S degree or 10 years' experience with a Ph.D. degree.
Master or Ph.D. of Science/engineering in Biology, chemistry, chemical engineering, or related discipline is preferred
Understanding of mammalian cell culture and downstream purification process development and scale up is a must.
cGMP experience is required.
Experience in vaccine research, development and clinical production is required.
Experience of IND and BLA CMC section writing is preferred.
Experience of FDA and EMA meeting and communication is preferred.
Experience with live virus and virus-like-particles is preferred.
Exceptional leadership skills and proven ability to interact effectively with all levels of organization.
Excellent management and communication skills.