At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The Bioproduct Research and Development (BRD) organization strives to deliver creative medicines to patients through the development and commercialization of insulins, oligonucleotides, monoclonal antibodies, novel therapeutic proteins, peptides and gene therapy systems. This organization is a multidisciplinary group that works collaboratively with our discovery and manufacturing colleagues. Located in Indianapolis, IN scientists have full access to our scientific excellence and engineering capabilities.

Responsibilities:

Support development, optimization, and implementation of assays to assess the biological activity of therapeutic proteins, peptides, antibody-conjugates and/or cell and gene therapies.

Support transfer of potency assays for QC release and stability testing to meet product requirements and corresponding regulatory requirements.

Responsible for execution of experiments, data review and analysis, document writing, and contributing to sections of regulatory submissions.

Support bioassay lab activities such as cell culturing, critical reagent acquisition, bioassay method qualification as well as instrument purchase and qualification.

Coordinate and collaborate with internal and external partners. Work in cross functional teams.

Assess and evaluate new technologies suitable for bioassay development.

Basic Requirements:

MS in Molecular Biology, Immunology, Biochemistry, Bioanalytical chemistry or related field or BS in Molecular Biology, Immunology, Biochemistry, Bioanalytical chemistry or related field and a minimum of 1-3 years’ experience in Pharma/Biotech industry

Hands-on experience in executing potency assays (binding assays, cell-based assays)

Additional Skills/Preferences:

Good interpersonal and communication skills.

Capability of managing workload.

Understanding of GMP quality systems.

Knowledge about FDA/EMA regulations on potency assay development.

Experience with automation such as liquid handlers, FACS, Biacore, qPCR/ddPCR.

Experience with statistical analysis of bioassays using software such as SoftMAX pro, PLA2.0, JMP (SAS).

Additional Information:

Location: Indianapolis: IN

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