(Archived) Research Scientist - Analytical Process 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.

Share your passion for innovation and complex problem solving with like-minded scientists at a cause-driven, customer focused company dedicated to positively impacting the health of animals, people and the planet.

The Technical Services & Manufacturing Sciences (TS/MS) team at Elanco Technology Center, Indianapolis plays a key role in continuous process and productivity improvements initiatives and support of Elanco’s network of manufacturing sites with a diverse portfolio of pharmaceutical and biotech products. This Senior Scientist role is ideal for the individual looking to make a meaningful impact while pursuing both their short- and long-term career goals. As a global leader in the animal health industry, Elanco offers a variety of career opportunities inside and outside of the Manufacturing & Quality function at exciting locations around the world.

Reporting to the Principal Research Scientist of the Elanco Tech Center, the incumbent will be responsible for providing technical and strategic direction for vaccine process optimization with a particular emphasis on the analytical methods within the Life Cycle Management (LCM) program. The incumbent will also support other platforms within the Biotech Network, including microbial fermentation and monoclonal antibodies. The incumbent will collaborate with Scientists/Engineers in multiple geographies to deliver on a technical agenda focusing on product innovation, portfolio expansion, and productivity. The position is based in Indianapolis, with a vibrant community, a thriving life sciences industry and top-rated academic institutions.

Key Objectives/Deliverables:

• Technical and strategic leadership of analytical assays relevant to the characterization and release of commercial biologicals as part of the life cycle management (LCM) activities at the Elanco Tech Center. Responsibilities include:
  • Manage scope, deliverables, and timelines to facilitate delivery of analytical assays for the LCM portfolio
  • Design, conduct, and oversee the execution of laboratory experiments
  • Establish appropriate and relevant characterization assays to enhance process development and optimization activities for biologicals
  • Utilize statistical modeling (DoE) approaches to deliver effective analytical solutions
  • Explore and champion emerging technologies that may be applied to the biological’s portfolio

• Propose, gain support for, and implement technologies from the incumbent’s experience and knowledge to enhance characterization and quantitation methods
• Prepare verification and validation studies in accordance with current regulatory compliance
• Provide technical leadership to the network organization regarding method development, improvements, and troubleshooting
• Participate in manufacturing site investigations as needed, enhancing analytical knowledge, understanding and problem solving
• Coach and grow technical talent at ETC and across the network
• Write technical papers and reports in a timely fashion
• Utilize safe laboratory practices, lead in safety compliance and improvement

Basic Requirements:

• B.S. (+8yrs), M.S. (+4yrs), PhD in biochemistry or other biotechnology related degree.
• Qualified candidates must be legally authorized to be employed in the United States.
• Experience with a variety of technologies and platforms is preferred including; ELISA, western blotting, SDS-PAGE, qPCR, calorimetric/fluorescent /luminescence based bioassays, HPLC, FPLC, viral titrations, virus neutralization, Immunodiffusion, serological assays, and immunofluorescence

Additional Skills and Preferences:

• Experience with additional analytical techniques
• Proven record of successfully troubleshooting bioanalytical methods
• Experience with biologicals manufacturing
• Knowledgeable in cell and egg-based assays (LD50/ED50) for viral titrations (TCID-50 and Plaque assay)
• Experience with monitoring and leading contract service provider relationships that support analytical development
• Experience on virus infection studies, nucleic acid extraction, set -up analytical assays
• Knowledge of vaccine workflow and handling of mammalian cell culture (including primary cells) and virus propagation
• Strong technical report writing skills and excellent communication skills,
• Experience with protein purification and characterization methods to assist in accomplishing milestones
• Proven organization and time management skills to meet time sensitive deadlines, attention to detail, and collaboration in a team-based environment are essential.
• Personal attributes: self-starter; attentive to details; results oriented; accountable; respectful of others; committed while maintaining balance and perspective; good written and oral communication skills.
• Ability to work in a fast-paced and dynamic environment with changing priorities, and flexibility to support multiple projects simultaneously.
• Ability to problem solve using innovative thinking and good decision making.
• Ability to influence people
• Ability to build collaborative relationships with areas inside and outside of Elanco
• Familiarity with Global Regulatory Standards (FDA, EU GMP, USDA)

Travel

• 0-10% Domestic and International travel

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