India Job Openings
Lilly
Advisor - Bioassay (Bioproducts Research and Development)
Indianapolis
FULL TIME
October 11, 2024
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:
- Ph D in immunology, virology, cell biology, molecular biology or equivalent field.
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, q PCR, dd PCR).
- Experience with statistical analysis of bioassays using software such as Soft MAX pro, PLA2.0, JMP (SAS).
- Experience in interactions regulatory agencies (IND/BLA submissions, Rt Qs, 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
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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