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At Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
Job description:
There is an exciting opportunity to join a dynamic process development team responsible for development and scale up of new biopharmaceutical and vaccine products. The Biopharma technical development team works collaboratively with an inclusive culture to deliver innovation for Elanco.
This is a Global Lead Scientist role responsible for developing process for biopharma projects in R&D pipelines with an emphasis on downstream purification processes. The individual is expected to provide overarching technical and scientific expertise for process development and commercialization activities of new drug substances. This position is expected to be a senior technical expert for R&D Elanco globally and will work collaboratively with management and global project groups in line with site, functional and corporate business goals.
The individual will be expected to lead downstream process development, scale up, technical transfers, process implementation, and material delivery activities for IVP or CT supply and registration. Additionally, the role will support process validation-related activities. The role is focused on ensuring that a robust manufacturing process is developed according to quality by design and ‘end in mind’ principles.
The role is expected to be hands on but will provide technical direction, coaching and mentoring to scientists.
Key Responsibilities:
- Provide technical leadership for downstream development (protein purification) from early through late phase large molecule projects, ensuring phase appropriate technical development and collaborating closely with relevant functions.
- Provide technical leadership/expertise for delivery of process development projects based in the laboratories and pilot plant areas.
- Ensure a sound laboratory/pilot plant program in alignment with global requirements, establishment of robust control strategies and successful product launch.
- Provide oversight for technical transfers and scale up into Speke pilot plant for delivery of pivotal materials.
- 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.
- Support successful commercialization of new products strategically and tactically by partnering across functions.
- 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.
- Participate in the evaluation of new business opportunities through the processes of due diligence, product reviews, and cost modelling.
- Serve as a technical resource across Elanco and apply technical expertise to scientific problems to support across the network.
- Responsible for coaching and mentoring development scientists.
- Ensure delivery of high-quality technical reports, provide technical review for team development reports.
- Foster a collaborative culture, develop internal and external links.
- Highlight new technologies, build future capabilities, and influence strategy.
Qualifications & experience:
- Preferred advanced degree in a scientific discipline (biochemistry, biotechnology/biologics or related discipline). Or degree with significant industrial experience.
- 10+ years of relevant experience in development/commercialization activities for pharmaceutical or vaccine products, or other relevant experience.
- Demonstrated success in the development and commercialization of new pharmaceutical or vaccine technologies (e.g. API, drug product, drug substance development; analytical method transfer; and/or packaging).
- Experience in regulated environments and working under Good Manufacturing Practices.
- Good knowledge and understanding of protein chemistry. Understanding of potential CQAs, process and product related impurities and stability needs.
- Strong problem-solving skills, including strategic and creative thinking.
- Strong interpersonal skills with demonstrated ability to collaborate with and influence teams.
- Ability to handle multiple priorities and deal with ambiguity.
- Strong presentation skills and scientific/technical writing skills.
- Ability to work in interdisciplinary teams, influence diverse groups and effectively manage relationships.
- Demonstrated ability to mentor and develop coworkers with a diverse background.
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
