Senior Biologist

About the role

The Bioproduct Research and Development (BR&D) organization delivers innovative medicines through the development and commercialization of insulins, peptides, oligonucleotides, monoclonal antibodies, ADCs, novel therapeutic proteins, and gene therapy systems. BR&D is a multidisciplinary group with deep scientific expertise that collaborates closely with discovery and manufacturing partners. Located in Indianapolis, IN, our scientists have access to world-class pharmaceutical development and engineering capabilities.

Responsibilities

• Support the development, optimization, and implementation of assays to assess the biological activity of therapeutic proteins, peptides, and new modalities, including gene and cell therapies, in the laboratory.
• Execute experiments, review and analyze data, author technical documents, and contribute to sections of regulatory submissions.
• Support bioassay lab operations, including cell culturing, reagent acquisition and qualification, and instrument purchase and qualification.
• Collaborate with internal and external partners as part of cross-functional teams.
• Evaluate and assess emerging technologies suitable for bioassay development.

Requirements

• MS in Molecular Biology, Immunology, Biochemistry, Bioanalytical Chemistry or a related field with a minimum of 0–2 years of experience in the pharma/biotech industry; or BS in Molecular Biology, Immunology, Biochemistry, Bioanalytical Chemistry, or a related field with a minimum of 2–3 years of experience in the pharma/biotech industry.
• Hands-on experience executing potency assays, such as binding assays (e.g., ELISA, SPR) and/or cell-based assays (e.g., luciferase reporter assays).
• Proficiency in mammalian cell culture techniques, including maintenance of adherent and suspension cell lines, passaging, and cryopreservation.
• Experience working with engineered cell lines (e.g., stable reporter lines, knockout or knock-in lines) commonly used in bioassay development and qualification.
• Strong interpersonal and communication skills, with the ability to collaborate effectively across cross-functional teams.
• Demonstrated ability to prioritize and manage workload in a fast-paced, deadline-driven environment.

Qualifications

• Basic qualifications: Authorization to work in the United States on a full-time basis.
• Additional skills/prefers: Experience with genome editing techniques, understanding of GMP quality systems, knowledge of FDA/EMA regulations governing potency assay development, experience with statistical analysis of bioassays.