Scientist Bioassay, GMP Testing Laboratories, BR&D

Industry:

Company: Eli Lilly and Company

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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Bioproduct Research and Development (BR&D) organization delivers new medicines to patients through the development and commercialization of insulins, peptides, oligonucleotides, monoclonal antibodies, novel therapeutic proteins, and gene therapy systems. BR&D is a multidisciplinary group with deep technical expertise that works collaboratively with our discovery and manufacturing colleagues. Located in Indianapolis, IN, scientists have full access to Lilly’s deep pharmaceutical development expertise and engineering capabilities.

Position Summary:

The Principal Scientist-Bioassay has responsibilities for the GMP laboratory areas within the BR&D Analytical Development Organization, which is focused on analytical method qualifications, validations, and transfers, as well as analytical release and stability testing for GMP drug substance and drug product.

Responsibilities:

• Responsible for execution of bioassays, data collection, data analysis, data recording in electronic notebooks, presentation, and preparation of technical reports
• Support bioassay development, optimization, and implementation to assess the biological activity of therapeutic proteins, peptides, monoclonal antibodies, antibody-conjugates, oligonucleotides, cell and gene therapies.
• Support transfer of cell-based potency assays and binding assays for QC release and stability testing to meet product requirements and corresponding regulatory requirements.
• Support bioassay lab activities such as cell culture and cell maintenance, identification and qualification of critical reagents, participation of bioassay qualification and validation, and maintenance of Lab instruments.
• Coordinate and collaborate with internal and external partners. Work in cross functional teams.
• Evaluate innovative technologies and automation suitable for bioassay development.

Basic Requirements:

• BS or MS in Biochemistry, Cell Biology, Molecular Biology, Immunology, immunology, virology, or equivalent field. A minimum of 1-3 years of hands-on experience in Pharma/Biotech industry. Academic scientists with strong technical skills and publications are also encouraged to apply.
• Hands-on experience in executing potency assays (cell-based assays, binding ELISA or homogenous TR-FRET).

Additional Preferences:

• Hands-on experience with Surface Plasmon Resonance (SPR) is strongly preferred.
• Good interpersonal and communication skills.
• Capability of managing workload.
• Knowledge about FDA/EMA regulations on potency assay development.
• Experience with cell flow cytometry, Biacore, qPCR/ddPCR, liquid handlers, or automation.
• Experience with statistical analysis of bioassays using software such as SoftMAX pro, PLA2.0, JMP (SAS).

Additional Information:

Location: Indianapolis: IN

Physical Demands/Travel:

The physical demands of this job are consistent with a lab environment

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment:

This position’s work environment is in a Laboratory.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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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