- Provide bioanalytical support for portfolio including complex method development and management of qualified or validated methods.
- Effective in providing oversight to CRO partners for non-regulated and regulated bioanalytical method development, validation, and sample analysis.
- Address bioanalytical challenges with innovative solutions.
- Collaborate and influence teams cross-functionally with discovery, non-clinical and clinical teams, as appropriate.
- Collaborate with Procurement, Quality, and Operations as needed.
- Builds relationships with internal customers and external vendors on bioanalytical method support, troubleshooting and critical reagent management.
- Bachelor's degree preferably in scientific field.
- Minimum of 3 years in a regulated bioanalytical laboratory setting.
- Understanding of the current ICH M10 BMV guidance requirements and GLP/GCP regulations.
- Experience with sponsor-vendor interactions and relationship building.
- Strong project management, driving to meet timelines for data delivery.
- Hands-on laboratory experience with small or large molecule LC-MS bioanalytical methods/assays including:LC-MS method development, validation, and sample analysis across various large molecule entities (e.g., small molecule, peptide, protein, ADC, oligonucleotide, ARC/AOC)Current understanding of small and large molecule sample preparation techniques (e.g., immunoprecipitation, protein digestion, solid-phase extraction, hybridization LC-MS) and relevance to complex drug modalitiesExperience with tissue homogenization and extraction processesPlatforms such as triple-quadrupole and high-resolution mass spectrometry and software packages such as Analyst, Excalibur, Chromeleon, SkyLine
- Excellent problem-solving skills, time management, organization, and follows through on commitments.
- Familiarity with related systems and applications (LIMS, eLNs, instrument software).
- Proficient written and spoken English language skills including effective verbal communication.
Senior Scientist - Indianapolis, United States - Lilly
Description
We're looking for people who are determined to make life better for people around the world.
Lilly is on the forefront of cutting-edge 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, energetic, 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 essential 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. We look forward to seeing your application and having you on our team
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 data needed to advance the Lilly portfolio.
Are you ready to work in an innovative team and impact lives around the world? Apply today
Responsibilities:
Minimum Qualification Requirements:
Additional Preferences
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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