Key Responsibilities / Deliverables
- Provide subject matter expertise for formulation development and identifying a lead formulation. Leverage knowledge/ experience to develop a robust manufacturing process.
- Build a formulations platform based upon technical innovation and an appropriate risk/phase-based approach.
- Ensure manufacturing concerns are addressed at phase-appropriate points of development; effectively apply principles of QbD.
- Manage project scope, deliverables, timelines and budget to facilitate delivery of Elanco’s pipeline.
- Write, review or approve high quality technical reports, SOP’s, batch records, global regulatory submissions and response to questions. Ensure that records and technical notebooks are adequately maintained.
- Lead the Manufacturability Review process, ensuring the delivery of an effective process/product control strategy. Play a leadership role in technical transfer, process implementation, and material delivery activities for pivotal CT and registration stability supply.
- Introduce new techniques and technologies. Keep pace with the expertise in the field and the competitive landscape.
- Identify, select and coordinate external consultants, CRO’s and CMO’s. Work effectively across all R&D teams, manufacturing and with external collaborators
- Enhance Elanco’s brand and competitive advantage by patents, presentations, publications and professional activities.
- Ph.D. level +6 years relevant experience supporting formulation and manufacturing of biologics drug product.
- Qualified candidates must be legally authorized to be employed in the United States.
Additional Skills/ Preferences
- Credible, high performing person with a track record of successfully managing major projects and influencing/directing teams.
- Ability to network and communicate with management of various functions; strong cross-functional overview.
- Prior relevant process/product commercialization experience with a focus on process robustness/reliability and effective control strategy development.
- Experience in regulated manufacturing environments (cGMP, EPA, USDA).
- Understanding of or experience in multiple technology platforms (e.g. fermentation, downstream processing, formulations).
- Demonstrated ability to supervise/manage others, ability to motivate and influence personnel within the department and in other associated work groups.
- Strong problem-solving skills including strategic and creative thinking.
- Strong interpersonal skills. Demonstrated ability to collaborate with and influence teams.
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