Responsibilities:
1. Provide technical leadership for upstream development (cell culture and/or fermentation and clarification) for early through late phase large molecule development projects, ensuring phase appropriate technical development and collaborating closely with relevant functions.
2. Provide technical leadership/expertise for delivery of process development projects based in the development laboratories and pilot plant areas.Provide oversight for technical transfers and scale up into Speke pilot plant for delivery of pivotal materials. Ensure a sound laboratory/pilot plant program in alignment with global requirements, establishment of robust control strategies and successful product launch. Ensure that project work is carried out with necessary scientific rigor across the team for quality data output. Responsible for ensuring use of sound statistical data methodology to design and execute experimental work as part of routine day-to-day projects. Lead Quality by Design and applying principles for development of control strategy and design space through experimentation.
3. Support successful commercialization of new products strategically and tactically by partnering across functions.
4. Provide leadership for technical transfers, process implementation, and material delivery activities for pivotal Investigational Product (IVP or CT) supply, registration, and validation batches internally or with external partners.
5. Participate in the evaluation of new business opportunities through the processes of due diligence, product reviews, and cost modelling.
6. Serve as a technical resource across Elanco and apply technical expertise to scientific problems to support across the network.
7. Responsible for coaching and mentoring development scientists.
8. Ensure delivery of high-quality technical reports, provide technical review for team development reports.
9. Foster a collaborative culture, develop internal and external links.
10. Highlight new technologies, build future capabilities, and influence strategy.
Qualifications & experience:
11. Preferred Degree or advanced degree in a scientific discipline (biochemistry, biotechnology/biologics or related discipline) or other relevant experience in a science field.
12. 10+ years of relevant experience in development/commercialization activities for pharmaceutical or vaccine products
13. Demonstrated success in the development and commercialization of new pharmaceutical or vaccine technologies ( API, drug product, drug substance development; analytical method transfer; and/or packaging).
14. Experience in regulated environments and working under Good Manufacturing Practices.
15. Good knowledge and understanding of protein chemistry. Understanding of potential CQAs, process and product related impurities and stability needs.
16. Strong problem-solving skills, including strategic and creative thinking.
17. Strong interpersonal skills with demonstrated ability to collaborate with and influence teams.
18. Ability to handle multiple priorities and deal with ambiguity.
19. Strong presentation skills and scientific/technical writing skills.
20. Ability to work in interdisciplinary teams, influence diverse groups and effectively manage relationships.
21. Demonstrated ability to mentor and develop coworkers with a diverse background.