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The Global FA Vaccine Process/Analytical Leader is responsible for process and analytical development of global food animal vaccines from positive proof of concept to registration. Accountable for the timely progression of assigned development projects through product development stage gate promotion process via leveraging effective project management skills, people leadership skills, Clinical development expertise and technical development expertise. Specifically, this role provides process development & analytics subject matter expertise. The role has the following core responsibilities:
Define overall strategy for submission as a process development & analytics subject matter expert (SME), in collaboration with cross functional teams involved in licensing vaccine products for poultry, cattle, swine and aqua.
Ensure the collection of accurate and complete upstream, downstream, formulation, and test method datasets to fulfill the requirements for vaccines licensure by global competent authorities,
Contribute as SME on product line extensions and product remediation projects.
Build and maintain strong relationships with functional partners in manufacturing, regulatory, quality, commercial, as well as other areas of R&D, to progress projects.
Plan, coordinate, and advise on process development & analytics activities required for registration / licensing of new vaccines projects, as well as product line extension and product remediation projects involving international teams.
Contribute to and/or lead vaccine development projects with strong strategic focus, quality awareness, scientific, and technical expertise.
Ensure implementation of decisions and strategies for process and analytical development and ensure alignment of strategy with other project technical functions required for marketing authorization.
Partner with the Project Manager to proactively develop and communicate budgets, overall project strategy, phase transitions, project deviations, key issues, and any other critical topics in a timely manner to management.
Represent the Project Team at scientific reviews and portfolio management boards. Report and present scientific/technical results internally.
Ensure critical project documentation is complete, accurate, and appropriately retained to ensure product development remains transparent and reproducible.
Evaluate/have input for protocols/reports and ensure they are appropriate for submissions.
Write and/or support the generation of international registration documents.
Work effectively and flexibly within and across Elanco Research & Development teams, as required.
Transfer knowledge and information from R&D to TS/MS, Manufacturing, AS&T, Quality Control, Quality Assurance, Regulatory and Commercial.
Provide technical strategy/advice based on regulations from different regions.
Pro-actively communicate project status and activities
Ph.D. or DVM (with at least 3 years industry experience) or M.S. degree (with at least 7 years industry experience) in Microbiology, Virology, Molecular Biology or related field; and/or experience in leading multi-disciplinary vaccine R&D teams in the animal health industry.
Proven leadership, communication skills, and leading without authority.
Ability to work in interdisciplinary, multinational and multifunctional teams.
Solid understanding of research and development process and regulatory submission process/ requirements within applicable EU Directives and Pharmacopoeia and USDA VSMs.
Practical understanding of GLP and GCP regulations as they apply to vaccine product development study design and regulatory compliance.
Understanding of USDA and/or EU regulations relating animal vaccines.
Proven ability to collaborate effectively across functions and provide leadership through influence.
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