This position directly supports the Large Molecule Technical Development organization. The primary responsibility of this role is to develop robust formulations and manufacturing processes needed to advance Elanco’s early and late phase biopharmaceutical portfolio for global markets. The formulations scientist will provide hands-on, day-to-day technical support of all formulation lab activities covering the broad scope of Elanco’s large molecule portfolio (Nutritionals, Vaccines and Biotherapeutics). This role involves establishing the formulation strategy, identifying future capability and transfer of robust process to manufacturing. Beyond the lab responsibilities, this role also includes authoring and executing SOPs, batch records and technical reports, preparation and review of the appropriate manufacturing and controls portion of regulatory submissions. This position is laboratory-based and will require routine interaction with scientists across discovery and development laboratories at Elanco. The ability to independently conceptualize and execute experiments, coupled with a “can do” attitude, is essential. The formulation scientist position is a high visibility position that serves as the lead scientist on various product and species teams in R&D. Beyond the technical requirements, this position will require organizational management and excellent communication skills. It is expected that the person in this role will become an independent leader for the group and within the various CMC product teams.
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 and global regulatory submissions. 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 or MS +6yrs relevant experience or BS +10 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.