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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 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 (BR&D) 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.

The qualified individual will work in a group responsible for the development of potency and other biological characterization assays to support bioproduct development. The candidate will be responsible for the development and implementation of biological assays in support of clinical development and regulatory submission. The candidate will be expected to communicate results effectively in presentation and written reports, and to participate in cross-functional teams.

Responsibilities:

• Develop and optimize assays to assess the biological activity of bioproducts such as antibodies, bispecific antibodies, multifunctional proteins, peptides as well as Cellular & Gene Therapy Products.

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

• Design, execute experiments, review data and conduct analysis

• Capture knowledge with appropriate documentation and contribute to sections of regulatory submissions.

• Familiarity with GMP quality systems

• Assess and evaluate new technologies suitable for bioassay development.

• Coordinate and collaborate with internal and external partners.

Basic Requirements:

• PhD in immunology, virology, cell biology, molecular biology or equivalent field.

• Experience of biologics development of therapeutics classes from mAbs, Antibody-conjugates, and cell or gene therapy.

Additional Skills/Preferences:

• Demonstrated experience in elucidating mechanism of action of molecules, understanding gene expression control, signal transduction pathways in fields on oncology, immunology, neurobiology or endocrinology.

• Experience with automation such as liquid handlers, FACS, Biacore and/or PCR (RT-PCR, qPCR, ddPCR).

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

• Experience in interactions regulatory agencies (IND/BLA submissions, RtQs, etc).

• Strong technical knowledge and experience with developing cell-based assays to support control strategy development and assess protein structure/function relationships

• Strong understanding of quality systems (GMP) and compliance guidelines.

• Knowledge about FDA/EMA regulations on potency assay development.

Additional Information:

• Location: Indianapolis, IN

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