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The Sr. Director of Vaccine Development is responsible for the leadership and administration of the global vaccine process, analytics, and drug product development scientists supporting Elanco’s vaccines R&D portfolio. This scope includes, but is not limited to the later phase vaccine portfolios for companion and food animals, nutritional health and early research. Within that portfolio support, the Vaccine Development Sr. Director will be directly responsible
for all aspects of analytical method development and control strategy as well as developing the processes for the originating antigen origination through the final formulations and drug product presentation.
In this role, the Sr. Director leads a global team of subject matter experts and research
facilities across North American (Fort Dodge, IA) and European (Cuxhaven, Germany) regions. This team and role support the R&D portfolio through resource and technology management of internal and external capabilities. This vaccine leader will closely partner with peers leading the Large and Small Molecule groups within PVS&T (Pharmaceutical, Vaccine Science & Technology).
Key Leadership Deliverables:
Lead a team of 20-35 multi-disciplined scientists and maintain key relationships with critical stakeholders (Product Development Teams, Manufacturing Technical Services, Global Operations, Quality, Research)
Set the vision and late phase strategy for Elanco’s vaccine platforms
Create and sustain a culture of high technical rigor and innovation
Implement and develop technical and professional capabilities to support process, analytics and formulations development to deliver the R&D portfolio
Provide technical leadership and coaching to ensure timely and successful delivery of project outcomes in accordance with key project milestones (data, control strategies and material)
Manage and prioritize resources (project and portfolio) to deliver against timelines and budgets
Develop personnel, manage and retain key talent, and effectively recruit to fill capability gaps
Co-lead R&D sites, along with Global Operations, and provide leadership for the R&D facilities including, HS&E, Quality, Regulatory, and Diversity and Inclusion initiatives
Liaise with Elanco Manufacturing and Quality representatives to develop sourcing strategies for commercial supply.
Drive and implement the biotech innovation strategy (technology, science, productivity)
Key Technical Deliverables:
Develop Elanco’s vaccines analytical and process strategy in close alignment with TSMS, Manufacturing, Regulatory and Quality to ensure robust processes are developed and commercialized
Enhance Elanco’s capabilities, including upstream, downstream, formulation development and control strategies
Build tools, systems, and business process to enable efficiency, effectiveness and quality in PVS&T and across development teams & critical partners
New scientist recruitment and development of scientists
Enable compliance with regulatory, safety, and performance standards
Facilitate efficient knowledge sharing across technical teams to ensure robust problem solving
Minimum Educational Qualification
BS, MS or Ph.D. in chemistry, engineering, and/or a biotechnology related field with at least 10 years of relevant experience working with vaccines
Ability to lead and develop scientists from a diverse set of backgrounds and with varied skill sets and competencies
Proven leadership with teams with a demonstrated ability to handle multiple priorities, manage ambiguity and show agility when dealing with dynamic change
Strong interpersonal skills with a demonstrated ability to collaborate with and influence teams
Ability to work in interdisciplinary teams, influence diverse groups and effectively manage relationships
Experience working in regulated environments (e.g. FDA, EMA, EPA, USDA, etc.) and working under current Good Manufacturing Practices
Strong problem solving skills, including strategic and creative thinking
Demonstrated experience in successfully managing major projects and influencing/directing teams
Ability to work successfully in international or multi-cultural settings
Additional Preferences / Experiences:
Strongly desired to have experience with establishing Process and Analytical Control Strategies for Vaccine
Demonstrated experience with building development timelines for process and analytical method development
Position may require up to 25% travel.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status