LEM Consultant – Immunogenicity Assay Implementation-CRO's
Eli Lilly - Indianapolis, IN

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City

Indianapolis

Position Locale

Local / Onsite

Location Details

Lilly Corporate Center

Company Overview

Lilly is the 10 th 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

Purpose:
The Laboratory for Experimental Medicine (LEM) develops clinical immunogenicity assays to support clinical trials for large molecules. LEM Associates are responsible for the development, validation and application of immunogenicity and novel biomarker assays. Associates in the LEM develop and characterize immunogenicity assays, then partner with external vendors to validate and implement these assays in clinical trials. The LEM consultant responsible for technical oversight of immunogenicity assay implementation and data generation at CRO’s will work with LEM associates to ensure that highest quality immunogenicity data is generated at performing CROs.

Key Objectives and Deliverables:
Research related to immunogenicity – Consultant will aid in the development and implementation of immunogenicity assays (both screening and neutralizing) to support clinical drug development by making sure that assays comply with most current FDA guidance.

Communication and information management

– Consultant will play key role in accurate record keeping of raw data and communication of assay performance and data to regulatory colleagues and clinical teams.

Technical writing

– Consultant will provide oversight to writing of qualification plans, validation plans and validation reports for all LEM-developed immunogenicity assays. Consultant will also be responsible for appropriate section writing/editing of any FDA BD documents for immunogenicity.

Application of regulatory requirements

– Consultant will ensure that all CRO laboratory procedures regarding clinical immunogenicity assays are conducted and documented according to appropriate regulations.

Technical process application and improvement

– Consultant will maintain and develop expertise and knowledge of real time data analysis for ongoing immunogenicity assays including raw tier 1-3 data review to ensure that assays are performing as expected.

Basic Qualifications

BS in basic science

Strong background in immunogenicity assays (including screening and neutralizing) with at least 5 years of industry experience in this specialized area

Experience with various assay platforms and multiple computer software applications as relates to application to screening and neutralizing immunogenicity assays

Note

: Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Skills/Preferences

Project Management – Consultant must manage multiple projects and meet timelines established by customers.

Experimental design; scientific approach to problem solving; method development, optimization and validation.

Ability to influence change, implement process improvement both internally as well as at performing CROs

Additional Information

LILLY USA, LLC IS AN EQUAL OPPORTUNITY EMPLOYER

Removal Date

10-Apr-2013

About this company
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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in...