(Archived) Research Scientist

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.

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 biopharmaceutical portfolio. 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.

In addition, this position is Greenfield 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. This is a high visibility position that serves as the lead scientist on various product and species teams in R&D. Furthermore; and 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.

Basic Minimum Qualifications:

• Ph.D. level + 5 years relevant experience or MS +10yrs relevant experience supporting formulation and manufacturing of biologics drug product.
• Qualified candidates must be legally authorized to be employed in the United States.

Job Responsibilities:

• 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.

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, USDA).
• Understanding of or experience in multiple technology platforms (e.g. sterile liquid/lyophilized formulations, lipid nanoparticles).
• 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.

Travel Percentage: 0-10%

Notification of Drug testing and Background Checks

Elanco conducts urinalysis drug testing as a mandatory part of its pre-employment application and background check process after acceptance of a conditional offer of employment by an applicant. The drug testing will be conducted by a certified laboratory/testing service selected by Elanco, in accordance with the procedures required by applicable state and federal law. Additionally, Elanco requires successful completion of a urinalysis drug test if it has reasonable suspicion that an employee is under the influence of drugs or alcohol which adversely affects or could adversely affect the employee's job performance as allowed by applicable law. Tested applicants will be given a copy of any positive test result. All test results shall be considered confidential and shall not be disclosed by Elanco, other than to those persons for whom such disclosure is necessary. Positive test results, or a refusal to consent to and participate in pre-employment drug testing, shall be grounds for denial of employment. Cooperation in scheduling the testing is important for processing an application for employment. By signing your acceptance to an offer of employment, you consent to be drug tested and acknowledge you have thoroughly read the foregoing notice and policy, and you understand and agree that in order to be considered for employment with Elanco, you will be required to comply with Elanco's drug testing policy. Elanco's background check requirements also include but are not limited to an acceptable criminal background check, educational verification, job history verification and motor vehicle report (if required to drive a company vehicle). If appropriate for the role, as outlined on the job posting, successful completion of Post Offer Exam, Work Simulation and/or Administrative Skills Testing may also be required.

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