As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals’ lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco’s promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
Biopharma Technical Development has an exciting opportunity for an analytical scientist to join our product development organization in Greenfield, IN USA.
The scientist will drive development of chromatographic, electrophoretic and LC/MS analytical methods for a wide variety of biopharmaceutical product portfolios.
This position is laboratory-based and will require routine interaction with scientists across multiple discovery and core research laboratories at Elanco. The incumbent scientist will be expected to support multiple projects at any given time. The scientist will independently plan, perform, interpret and report results of scientific experiments. Responsible for leading validation, verification and method transfer strategies within Elanco and across the global sites as well as at CRO’s. The scientist will also act as a mentor to other laboratory scientists by providing training and reviewing various methods and making recommended changes to scientific protocols and procedures. This position will also be responsible for implementing R&D strategies to optimize analytical methods through principles of quality by design (QbD).
Functions, Duties, Tasks
- Perform assay development and optimization of chromatographic, electrophoretic methods for biopharmaceutical and therapeutic vaccine products and their characterization.
- Develop innovative and novel chromatographic solution to deliver analytics for wide variety of formulations for drug substances and drug products.
- 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 up- and down- stream bioprocesses along with formulation development activities.
- Develop method validation and verification strategies. Provide guidance within Elanco global sites and work with CRO’s to achieve business objectives.
- Participates in technical teams by presenting results at team and business unit meetings.
- Author reports, prepare SOPs/working procedures. Review technical documents including analytical test procedures, qualification protocols, development reports and stability protocols.
- Train and coach other associates and scientists globally to facilitate knowledge exchange to ensure consistent practices between sites.
- Adhere to laboratory safety standards. Maintain instrumentation systems, consumables inventory in an organized manner and in an ever-ready state.
Minimum Qualification (education, experience and/or training, required certifications)
- Minimum BS with 12+ years or MS with 10+ degree experience in Analytical chemistry, Biochemistry, Biophysics or relevant scientific discipline in biotech/biopharmaceutical industry.
- Experience with large molecule analytical characterization (recombinant protein, monoclonal antibodies, oligonucleotides, peptides, etc.)
- In-depth knowledge and extensive hands-on experience in developing a variety of analytical methods like HPLC/UPLC-based methods like RP-HPLC, AEX, SEC, and affinity chromatography, electrophoretic methods like cIEF and capillary electrophoresis along with LC/MS methods.
- Experience in validation, transferring and qualifying analytical methods at CMOs for protein therapeutic development programs including familiarity with applicable GMP requirements.
- Strong Oral and written communication and organizational skills.
- Experience with various statistical methods including proficiency in various statistical software.
- Experience in using electronic laboratory notebooks.
- Highly focused and detail oriented, with high personal ethical and quality standards.
- Encompass a can-do attitude to drive productivity and efficiency.
- Must be able to work productively in an interdisciplinary team environment.
- Up to 5-10% travel required
- Onsite in Greenfield, IN (New campus opening in Indianapolis, IN soon)
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