Associate / Principal Scientist - Analytical Development

Elanco Tiergesundheit AG; Indianapolis (IN); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Relocation packages

Two weeklong shutdowns (US)

8-week parental leave

Employee Resource Groups

Annual bonus

Job summary

Elanco is seeking a Principal Scientist in Analytical Development to lead method development for therapeutic proteins across discovery to first product registration. The role requires hands-on leadership, strong analytical expertise, and collaboration with Global Quality, Regulatory Affairs-CMC, and manufacturing teams.

The ideal candidate will have extensive experience with biologics (mAb, complex proteins), state-of-the-art analytical techniques (UPLC/HPLC, SEC, IEX, RP-HPLC, LC/MS), and a

Qualifications

• Ph.D. or M.S./B.S. in analytical chemistry/biochemistry with extensive pharma industry experience.
• Experience leading analytical development for biologics and related modalities.
• Strong background in separations science and analytical method development.

Responsibilities

• Lead program-specific method development for biologics from discovery to regulatory filing.
• Provide hands-on technical leadership and cross-functional collaboration.
• Develop and transfer release, characterization, and stability assays.
• Mentor junior scientists and manage project timelines.

Skills

Analytical method development

Biologics analysis

UPLC/HPLC

SEC

IEX

RP-HPLC

Team leadership

Cross-functional collaboration

Education

Ph.D. in analytical chemistry/biochemistry

M.S. in analytical chemistry/biochemistry

B.S. in analytical chemistry/biochemistry

Tools

UPLC/HPLC

SEC

IEX

RP-HPLC

LC/MS

Job description

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. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. 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!

Associate / Principal Scientist - Analytical Development

The Large Molecule Technical Development organization of Elanco is hiring for a Principal Scientist to play an instrumental role in our organization! The Principal Scientist is a senior scientific role whose primary responsibility is to lead program-specific method development activities for therapeutic proteins in our company's biologics portfolio, from the discovery interface through first product registration. In this role, you will provide hands‑on, day‑to‑day technical and strategic leadership and work closely with cross functional teams in Analytical Development, Process Development, Global Quality and Regulatory Affairs‑CMC, and our partners in in the commercial/manufacturing to support commercialization of our company's large molecule products. The ideal candidate will have knowledge in the development of biologics, including monoclonal antibodies and complex protein modalities. Research and industry experience should demonstrate successful application and management of state‑of‑the‑art analytical techniques to solve problems, including strong background and experience in separations science and extensive experience with UPLC/HPLC analysis of biologics (e.g. SEC, RP, IEX). Experience in microbiological techniques, ELISA, PCR and cell‑based analytics is preferred. We are looking for a team player with strong leadership skills and the passion for mentoring and working along others in a laboratory setting. Applicants must have effective organizational and multi‑tasking skills, have demonstrated excellent scientific leadership, and have superior communications skills, both written and oral. A track record of delivering impactful solutions to complex problems, and evidence of strong cross‑functional collaboration is expected. Experience leading small groups of technical personnel, leading projects, and defining group or departmental strategy will aid in distinguishing candidates.

Job Responsibilities:

• Extensive experience in analysis of biologics (e.g., Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX) RP-HPLC and affinity chromatography.
• Strong background in electrophoretic methods like cIEF and capillary electrophoresis along with LC/MS methods
• Strong background in analytical control strategy development and execution
• Demonstrated ability to develop talent through good mentoring skills
• Demonstrated ability for taking initiative, creativity, and innovation in problem solving
• Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications
• Ability to design, execute and/or direct the development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development
• A strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross‑functionally for successful transfer of assays; Plan assay optimization and documentation to meet program deadlines
• Authoring and reviewing internal technical reports, sections of regulatory filings and external scientific publications
• Experience with matrix management and peer to peer coaching
• Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.

Basic Minimum Qualifications:

• 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.

Preferred Experience and Skills:

• Experience with qualification, validation, and transfer of assays to a GLP or regulated laboratory environment as listed in ICH Q2 and USP
• Knowledge and experience with structure‑function assays and link to mechanisms of actions
• Understanding of protein degradation mechanisms and link between analytical methodologies for analysis
• Experience with complex glycan analysis
• Experience in analysis of various Biologic modalities (e.g., mAb, antibody‑drug conjugate, fusion protein).
• Established scientific reputation supported by publications and external presentations
• Strong interpersonal skills.
• Demonstrated ability to collaborate with and influence teams

Additional Information

Location: Global Elanco Headquarters - Greenfield, IN (NEW HEADQUARTERS COMING Q1 INDIANAPOLIS, IN)

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

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

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Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.