This position directly supports the Elanco’s Technical Development (TD) Organization in its mission to deliver Innovation, Characterization and Control. The primary responsibilities of this role are to lead and drive the next generation Mammalian Cell Culture 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. The cell culture principle research scientist will provide hands-on, day-to-day technical and strategic leadership and support of all upstream lab activities covering the broad scope of Elanco’s large molecule portfolio with initial emphasis on delivering Elanco’s therapeutic monoclonal antibody platforms.
The Cell Culture, Principle Research Scientist is a high visibility position that serves as the lead scientist on the various CM&C, product development and species teams within R&D and Manufacturing. This position will require organizational management and excellent communication skills. It is expected that 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 up to 1-4 direct reports and be looked to for establishing upstream processing strategy and identifying future capability. The role primarily supports development mode activities but they will also help to build and maintain some GMP/USDA capabilities and capacity.
In addition, the scientist will have access to high-throughput automation systems, lab scale models and pilot scale demonstration capabilities. The contributions from this scientist 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:
- Experimental design and analysis of cell culture operations (fed-batch and perfusion)
- Technical program leadership
- Lab supervision
- Collaboration with internal and external partners and technology transfer with manufacturing partners.
- This role’s deliverables will additionally include authoring and executing protocols, batch records and technical reports.
Upstream Process Development:
- Provide subject matter expertise to the mammalian cell culture processes and seed train expansion. Leverage knowledge/experience to accelerate and optimize the protein production.
- Build an upstream platform based upon technical innovation, solid business understanding, and an appropriate 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
- Provide Individual Contributor expertise with personal development into a leading strategic influencer
- Development high throughput bioreactor capabilities to support:
- Productivity optimization
- Cell Culture Design Space definition
- Discovery enablement (material supply)
- Establishing robust Control Strategy
- 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 with 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
- PhD (+4yrs) in engineering, biochemistry or other biotechnology related degree
- Experience working with mammalian cell culture of large molecule product streams (Monoclonal Antibodies, Proteins, Antigens….)
- Qualified candidates must be legally authorized to be employed in the United States
Additional Skills & Preferences:
- Experience with fed-batch and/or perfusion 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
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