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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!
Associate/Principal Scientist – Analytical Development
The Large Molecule Technical Development organization of Elanco is seeking a motivated scientist with technical expertise in Biologics Potency assays with a strong background in microbiological techniques, ELISA, PCR and cell-based analytics. More specifically, the ideal candidate will be a recognized expert developing mechanism-of-action reflective potency assays for the development of therapeutic proteins, monoclonal antibodies, antibody-drug conjugates, and/or new modality-based products.
The successful candidate is expected to provide scientific leadership, expertise, and creativity to solve complex project problems across the large molecule portfolio. Responsibilities include representing the group on product development teams and defining the potency strategy for a portion of our large molecule portfolio, oversight of method development and testing, and scientific mentoring. 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.
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:
• Expertise in cell-based assays, with application to solve complex scientific and operational challenges related to designing and developing GxP potency assays to support a variety of large molecule modalities, preferably with experience in new modality-based therapy development.
• Expertise in a variety of functional potency assay technologies
• Strong knowledge and statistical skills for interpretation of potency data in context of broader process and product development
• 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 5-8 years of experience in the pharmaceutical industry, M.S. in analytical chemistry/biochemistry or related field with a minimum of 10-12 years of experience in the pharmaceutical industry, or B.S. in analytical chemistry/biochemistry or related field with a minimum of 14-16 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
• 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 – Hybrid Work Environment
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
