Distinguished Research Scientist - Product Development
As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals’ lives better makes life better. Since 1954, we have provided solutions that support veterinarians, farmers, and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco’s promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth, and well-being.
Share your passion for innovation and product development working with like-minded scientists and leaders at a cause-driven, customer focused company dedicated to positively impacting the health of animals, people, and the planet.
The Upstream Process Development Group Leader directly supports Elanco’s Technical Development (TD) organization in its mission to develop and deliver Innovation, Characterization, and Process Control. The primary responsibilities of this role are to lead the upstream (cell culture, fermentation, etc) scientific team and drive the next generation of process strategies, to characterize and control product quality, and to develop the robust upstream processes needed to advance Elanco’s early and late phase biomolecules portfolio. You will provide day-to-day technical and strategic leadership and support all upstream lab activities within the broad scope of Elanco’s large molecule portfolio with initial emphasis on delivering Elanco’s therapeutic monoclonal antibody platforms.
In addition, this is a high visibility position that serves as the lead scientist on the various product development teams within R&D and Manufacturing and will require organizational management and excellent communication skills.
It is expected the person in this role is an independent, influential leader for the upstream group, the Technical Development organization, and throughout the various product teams. This role will have responsibility for ~10 reports and is expected to establish upstream processing strategy and identify future capability needs. This role primarily supports development mode activities but must be knowledgeable of GMP/regulated aspects of process commercialization. You will have access to high-throughput automation systems, lab scale models, and pilot scale demonstration capabilities. The contributions from this scientific leader role will range from initial capability screening during discovery phase evaluation to characterizing and optimizing product attributes and process operations in preparation for commercialization.
Responsibilities will include but are not limited to:
- Scientifically and administratively lead the Upstream Process Development Group
- Contribute to business and strategic plan development
- Ensure team members are growing scientifically and professionally thru direct and indirect coaching and mentorship
- Technical program leadership, lab supervision
- Incorporate effective/efficient develop approaches including experimental design and analysis of cell culture operations
- Collaboration with internal and external partners and technology transfer with manufacturing partners.
- This role’s deliverables may additionally include authoring/reviewing and executing protocols, batch records, and technical reports.
Upstream Process Development:
- Establish and prosecute Technical Development’s upstream process strategy coordinating with both Research and Manufacturing
- Provide subject matter expertise to the mammalian cell culture processes and seed train expansion. Leverage knowledge/experience to accelerate and optimize protein production.
- Build upstream platform(s) based upon technical innovation, solid business understanding, and a phase-appropriate risk approach
- Introduce new techniques and technologies. Keep pace with the expertise in the field and the competitive landscape
- Support Vaccines and Biotherapeutics process development
- Development high throughput bioreactor capabilities to support
- Productivity optimization
- Cell Culture Design Space definition
- Discovery enablement (material supply)
- Robust Control Strategy establishment
- Media development and optimization
- Cell Culture commercialization
- Manage project scope, deliverables, timelines and budget to facilitate delivery of Elanco’s pipeline
- Work effectively across all R&D teams, manufacturing and external collaborators
- Facilitate technology transfer with internal and external partners
- Author technical reports, SOP’s, batch records and tech transfer documents
- Identify, select, and coordinate external consultants, CRO’s and CMO’s. Establish contract agreements and maintain positive business collaborations
Basic Minimum Qualifications:
- PhD in engineering, biochemistry or other biotechnology related degree plus
- 12 years experience in animal health product development research
- Experience working with mammalian cell culture of large molecule product streams (Monoclonal Antibodies, Proteins, Antigens….)
Additional Skills & Preferences:
- Experience with fed-batch, perfusion and/or intensified fed-batch cell culture
- Experience with high-throughput capabilities for cell culture screening and process development
- Experience with cell culture scale-up and technology transfer
- Experience or understanding with Continuous Bioprocess Control Strategy
- Experience working in regulated (e.g. cGMP, USDA) and BSL 1 & 2 environments
- Strong problem-solving skills including strategic and creative thinking
- Understanding of or experience with multiple technology platforms (e.g., fermentation, analytical method development, purification formulations)
- Strong interpersonal skills. Demonstrated ability to collaborate with and influence teams
- 0-10% of travel (both domestic and international)
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
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