- Support development, optimization, and implementation of assays to assess the biological activity of therapeutic proteins/peptides and new modalities/ Gene and Cell Line Therapies in the laboratory.
- 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, reagent acquisition and qualifications, 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 with 2+ years of industry experience OR BS with minimum of 5+ years of experience.
Additional Skills/Preferences: - Hands-on experience in executing potency assays (binding assays, cell-based assays)
- Experience with working with biologics such as proteins, antibodies, ADCs, gene therapy or cell therapies
- Understanding of the application of bioassays in analytical control strategies
- 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 Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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Principal Biologist - Indianapolis, United States - Eli Lilly and Company
Description
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.
Responsibilities: