Senior Research Scientist Information Technology (IT) - Indianapolis, IN at Geebo

Senior Research Scientist

Company Name:
Eli Lilly
Company Overview:
Lilly is the 10th largest pharmaceutical company in the world, and has been creating medicines that help improve peoples' quality of life for more than 135 years. Across the globe, we are a leader in investing in research and development and we also invest in our employees in competitive salaries, training and development, and health.
The pharmaceutical industry is a complex, rapidly changing environment and we are looking for highly capable leaders to help us continue bringing innovation to patients.
If you are interested in being considered for employment at Lilly, we encourage you to review the following opportunity.
Responsibilities:
The Department of Drug Disposition (ADME) is a multidisciplinary group, utilizing in vitro, in vivo, and in silico approaches to study the pharmacokinetics, absorption, and disposition of new chemical entities. The scientist will function as a lead scientist in a cross-functional team environment, with primary responsibility for the drug disposition aspects of the development and registration of a growing portfolio of therapeutic proteins. The successful candidate will also collaborate with Drug Disposition scientists who focus on discovery and preclinical optimization of protein therapeutics/antibodies. Specific responsibilities include:
Provide ADME expertise and scientific leadership for the nonclinical and clinical development and registration of therapeutic proteins and antibodies.
Author/coauthor global regulatory submission documents and represent the team at regulatory meetings.
Design, analyze and interpret Drug Disposition studies, utilizing Contract Research Organizations as needed.
Collaborate on a multidisciplinary team of scientists (clinical PK/PD, clinical pharmacology, and statistics) to design and implement Clinical Pharmacology plans for protein therapeutics/antibodies.
Collaborate with Nonclinical Safety Assessment scientists in the evaluation of immunogenicity and other toxicology issues.
Collaborate with bio analytical scientists in the development, validation, implementation and troubleshooting of assays to measure concentrations of therapeutic proteins or antibodies in biological matrices.
Basic
Qualifications:
Ph.D. in biochemistry, molecular biology, pharmaceutics, pharmacokinetics or related discipline.
3
years of experience with large molecules (i.e. therapeutic proteins/antibodies/peptides) in the Pharma or Biotech industry, focusing on pharmacokinetics, absorption, bioanalysis, and disposition.
Prior experience with regulatory interactions related to pharmacokinetics, absorption, and disposition of large molecule drug candidates.
Additional Skills/Preferences:
Knowledgeable of current trends and thinking of regulatory authorities on scientific issues related to drug disposition of therapeutic proteins/antibodies.
Demonstrated experience in addressing immunogenicity issues.
Prior experience in the development and validation of immunoassays or other bio analytical methods used for therapeutic proteins and antibodies.
Training or experience in protein engineering or bio product optimization.
Prior experience collaborating with CMC scientists in establishing comparability in the manufacture of therapeutic proteins/antibodies.
Additional Information:
Lilly is an EEO/Affirmative Action Employer, and does not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status.Estimated Salary: $20 to $28 per hour based on qualifications.

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