Associate / Principal Scientist - Analytical Development

Elanco•Indianapolis, IN

1d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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
Experience in microbiological techniques, ELISA, PCR and cell-based analytics is preferred.
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).
Strong leadership skills and the passion for mentoring and working along others in a laboratory setting.
Effective organizational and multi-tasking skills.
Demonstrated excellent scientific leadership.
Superior communications skills, both written and oral.
A track record of delivering impactful solutions to complex problems.
Evidence of strong cross-functional collaboration.
Experience leading small groups of technical personnel, leading projects, and defining group or departmental strategy.

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.