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Principal Scientist - Biologics Analytical Development

Elanco Animal Health Incorporated
Indianapolis, IN Full Time
POSTED ON 2/9/2025
AVAILABLE BEFORE 5/7/2025

At Elanco (NYSE : ELAN) - it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability - the Elanco Healthy Purpose™ - to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals' lives better makes life better - join our team today!

Your Role : Principal Scientist - Biologics Analytical Development

As a Principal Scientist - Biologics Analytical Development on Elanco's Large Molecule Technical Development organization you will be leading method development for therapeutic proteins in our biologics portfolio. This role drives programs from discovery through first product registration, offering both hands-on and strategic leadership. You will collaborate with cross-functional teams in Analytical Development, Process Development, Global Quality, Regulatory Affairs-CMC, and commercial manufacturing to bring innovative large molecule products to market.

We're looking for expertise in biologics development, including monoclonal antibodies and complex protein modalities. The ideal candidate will have deep experience in separations science, UPLC / HPLC techniques (e.g., SEC, RP, IEX), and familiarity with microbiological methods, ELISA, PCR, and cell-based analytics.

This position requires a team player with proven leadership skills, a passion for mentoring, and a strong track record of solving complex problems. Successful candidates will excel in cross-functional collaboration, effective communication, and project leadership, with a focus on delivering impactful solutions that drive our mission forward.

Your Responsibilities :

  • Conduct and lead advanced analyses of biologics using techniques such as Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX), RP-HPLC, and affinity chromatography.
  • Utilize expertise in electrophoretic methods, including cIEF and capillary electrophoresis, as well as LC / MS techniques, to support analytical development initiatives.
  • Develop and execute robust analytical control strategies to ensure consistency, reliability, and compliance with regulatory requirements.
  • Mentor and develop team members, fostering talent growth and scientific excellence within the organization.
  • Proactively identify and implement creative solutions to complex analytical challenges through innovation and problem-solving.
  • Design and oversee the development, qualification, and execution of assays for release, characterization, and stability testing to support clinical trials and product development.
  • Collaborate cross-functionally to optimize assays, ensure smooth transfer between teams, and meet project deadlines effectively.
  • Author and review technical reports, regulatory submission documents, and scientific publications to support product development and compliance.
  • Manage projects and teams in a matrixed environment, providing peer coaching and ensuring alignment with organizational objectives.
  • Deliver complex project objectives under tight timelines, maintaining agility in a dynamic and evolving environment.

What You Need to Succeed (minimum qualifications) :

  • Education : Ph.D. in analytical chemistry / biochemistry or related field with a minimum of 8 years of experience in the pharmaceutical industry, M.S. in analytical chemistry / biochemistry or related field with a minimum of 12 years of experience in the pharmaceutical industry, or B.S. in analytical chemistry / biochemistry or related field with a minimum of 16 years of experience in the pharmaceutical industry.
  • Experience : A minimum of 8 years of experience in analytical development and method creation and validation in biologics
  • Top 2 skills : Strong hands-on experience in Analytical Development and a proven track record in effective team management.
  • What will give you a competitive edge (preferred qualifications) :

  • Experience with qualification, validation, and transfer of assays to GLP or regulated laboratory environments, as outlined in ICH Q2 and USP.
  • Knowledge of structure-function assays and their connection to mechanisms of action.
  • Understanding of protein degradation mechanisms and the link between analytical methodologies for analysis.
  • Experience with complex glycan analysis and various biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein).
  • Established scientific reputation, supported by publications and external presentations, along with strong interpersonal skills and demonstrated ability to collaborate with and influence teams.
  • Additional Information

  • Location : Global Elanco Headquarters - Greenfield, IN (NEW HEADQUARTERS COMING Q1 INDIANAPOLIS, IN)
  • Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

    Elanco Benefits and Perks :

    We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include :

  • Multiple relocation packages
  • Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
  • 8-week parental leave
  • 9 Employee Resource Groups
  • Annual bonus offering
  • Flexible work arrangements
  • Up to 6% 401K matching
  • 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

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