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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!
The TSMS, Sr. Analytical Scientist is responsible for providing technical and strategic direction for development and optimization of analytical methods supporting monoclonal antibodies (mAb) production within the Elwood manufacturing facility. This position will collaborate with Scientists/Engineers in multiple geographies to deliver on a technical agenda focusing on product innovation, portfolio expansion, and productivity.
Provide technical leadership to the Elwood site regarding method development, improvements, method qualification / validation and troubleshooting. Coach and develop team members to identify strengths and opportunities thus growing the technical ability of the team.
Functions, Duties, Tasks:
In-depth knowledge and extensive hands-on experience in developing a variety of analytical methods for release and characterization of mAb drug substances and drub products including: HPLC/UPLC, size exclusion chromatography, electrophoretic methods like cIEF and capillary electrophoresis along with LC/MS methods.
Participate in manufacturing site investigations as needed, enhancing analytical knowledge, understanding and problem solving.
Contribute to the development of analytical control strategy and setting specifications. Must have ability to think critically, demonstrate curiosity, trouble shoot and solve complex problems.
Provide rapid and timely analytical support for upstream and downstream bioprocesses along with formulation activities.
Advises, guides and coaches analytical associates for the purpose of ensuring routine operational support, identifying solutions and improvement, solving problems, decision making and communication including quality of written reports.
Ensures adherence to cGMP requirements, guidelines, SOPs, as well as compliance with local laws, the Elanco company policies and Health Safety & Environment (HSE) requirements.
Stays abreast of technological, regulatory and industry developments, e.g., via internal and external benchmarking.
Other duties as required.
Minimum Qualifications:
Bachelors of Science and 8+ years experience in Analytical chemistry, Biochemistry, Biophysics or relevant scientific discipline in biotech/biopharmaceuticals.
Proven organization and time management skills to meet time sensitive deadlines, attention to detail, and collaboration in a team-based environment.
Experience with large molecule characterization (recombinant protein, monoclonal antibodies, oligonucleotides, peptides, etc.)
Experience in validation, transferring and qualifying analytical methods at CMOs for protein therapeutic development programs including familiarity with applicable GMP requirements.
Demonstrated understanding of Q culture, cGMP standards, and regulatory regulations.
Additional Preferences:
Masters of Science or a PhD and 4+ years' experience in Analytical chemistry, Biochemistry, Biophysics or relevant scientific discipline in biotech/biopharmaceuticals.
Experience with various statistical methods including proficiency in various statistical software.
Highly focused and detail oriented, with high personal ethical and quality standards.
Must be able to work productively in an interdisciplinary team environment.
Understanding of USDA, FDA, and EU GMP regulatory standards for veterinary biologics.
Ability to network and build strong, collaborative relationships across functions / geographies.
Other Information:
Location: Onsite Elwood, KS (Relocation provided for qualified candidates).
Shift: Day position. Weekend and evening work not usual, although may be required to provide process support to ongoing operations.
Travel: Minimal < 10%.
Post offer Requirements: Completion of Post Offer Exam (POE), Completion of Work Simulation (SIM) or Completion of Administrative Skills Testing if applicable.
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
