Advisor- Bioanalytical

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 35,000 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:

Lilly is on the forefront of ground breaking research and has established the Lilly Institute of New Genetics Medicine. The Biotechnology Research/ADME-PK group is looking for scientists interested in pioneering novel drug modalities to join us in this effort. We seek dynamic, upbeat, collaborative scientists to work on life-changing therapies for patients involving novel complex molecules including DNA and RNA-based technologies. You will have the opportunity to engage with diverse teams in a 'biotech-like' manner within the walls of Lilly where innovative ways of thinking are crucial to advance these innovative platforms.

Our ADME team works seamlessly across analytical platforms to address the evolving bioanalytical challenges in discovery research. We seek highly motivated and dedicated scientists to join our fast-paced, interdisciplinary team. The successful applicants will have a working understanding of development and validation of bioanalytical methods and studies performed in an industrial setting. The bioanalytical scientist in this role will interact with various project teams as it relates to ADME activities at Lilly.

The bioanalytical outsourcing team supports all modalities including small molecules, oligonucleotides, peptides, biologics, and gene therapies across analytical platforms (e.g., ligand binding, LC-MS, PCR). Together, we ensure the delivery of the bioanalytical results needed to advance the Lilly portfolio.

Do you want to be a part of our bioanalytical team? Apply today to join the Lilly team!

Responsibilities:

• Provide bioanalytical support for portfolio including sophisticated method development and management of qualified or validated methods.
• Address bioanalytical challenges with inventive solutions.
• Collaborate cross-functionally with discovery, non-clinical and clinical teams, as appropriate.
• Collaborate with Procurement, Quality, and R&D Operations as needed.
• Serve as a mentor and a subject matter expert for bioanalysis of large molecule modalities.
• Interact with internal customers and external vendors on bioanalytical method support, troubleshooting and critical reagent management.
• Identify pioneering, innovative bioanalytical opportunities to solve analytical issues like increased sensitivity and method robustness for biologic therapeutics.

Minimum Qualification Requirements:

• Doctor of Philosophy (PhD) in field related to Analytical Chemistry, Cell Biology, Drug Metabolism and Pharmacokinetics (DMPK) or Pharmaceutical Sciences
• M.S. or B.S. with extensive regulated bioanalytical experience (or equivalent experience).
• 2 years of proven experience in industry setting with familiarity of regulatory landscape.

Additional Preferences:

• Understanding of the current ICH M10 BMV guidance requirements and GLP/GCP regulations
• Hands-on laboratory experience with large molecule bioanalytical methods/assays including:
• Immunoassay method development, validation, and sample analysis across various large molecule entities (e.g., mAb, ADC, oligonucleotide)
• Current understanding of immunogenicity techniques (e.g., ACE, PANDA, SPEAD, etc.) and relevance to complex drug modalities
• Immunoprecipitation methods for large molecule analysis using LCMS
• Large molecule assay workflows, knowledge of protein labeling, characterization and purification techniques
• Platforms such as ELISA, MSD, Gyros, Singulex, and HRMS
• Bioanalytical requirements for Gene Therapeutics, e.g., tissue isolation techniques for vector genome and % Ligation analysis, transgene expression, on and off-target analyses, etc.
• PCR primer and probe design for qPCR and dPCR methodologies
• Flow cytometry and cell based activity assays
• Immunohistochemistry and in situ hybridization method development.
• Excellent problem-solving skills, time management, and strong initiative
• Familiarity with related systems and applications (LIMS, eLNs, instrument software)
• Proficient written and spoken English language skills including effective verbal communication

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 ( [email protected] ) 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.

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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