Advisor, Analytical Development-CMC (Cell and Molecular Biology)

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.

The Analytical Development group is responsible for developing and implementing new analytical methods, as well as optimizing and improving current methods for the characterization of raw materials, RNA drug substances, and LNP products and programs at various development stages.

Additionally, the role includes testing non-GMP samples to support development studies such as comparability assessments, process development, stability, product, and process characterization. The position is part of a Technical Operations team that partners closely with Quality Control, Quality Assurance, Process Development, Analytical Research & Development, and other teams.

• Lead the development, optimization and qualification of analytical methods intended for a variety of purposes, including release and stability testing, product characterization, high-throughput analysis, and characterization of complex raw materials.
• Partner across the Analytical Development team and cross-functionally with BR&D and SMDD to lead, plan, and execute complex studies; serve as the analytical lead in cross-functional interactions.
• Develop and implement methods intended for product characterization to support late stage and commercialization of gene editing programs.
• Work in partnership with internal and/or external QC to coordinate analytical method transfer within the organization or at Contract Manufacturing Organizations (CMOs)/Contract Testing Laboratories (CTLs).
• Provide technical oversight for troubleshooting and phase-appropriate qualification and validation of analytical assays for the analysis of gRNA, mRNA, and LNP.
• Review, interpret, and present data within the analytical team and cross-functionally.
• Author, review, and revise technical source documents to support phase-appropriate comparability.
• Serve as the CMC representative on cross-functional project teams.
• Provide technical oversight to guide manufacturing and analytical/QC investigations, as needed.
• Train and mentor junior team members.
• Other duties as assigned.

Basic Requirements: 

• PhD in Molecular Biology, Cell Biology, Biochemistry, Microbiology or a related field, with 5+ years of experience in biotech/pharmaceutical industry, specifically in cell-based assay development.

OR

• MS in Molecular Biology, Cell Biology, Biochemistry, Microbiology or a related field, with 10+ years of experience in biotech/pharmaceutical industry, specifically in cell-based assay development.

Additional Skills/Preferences:

• Hands-on experience developing and troubleshooting molecular and cell-based analytical methods applied to complex and heterogeneous systems.
• Excellent scientific knowledge in biochemistry, cell biology and molecular biology with a conceptual understanding of strategies for method development and troubleshooting.
• Experience in developing cell-based potency assays is highly preferred.
• Advanced understanding of lipid nanoparticle delivery, production, and purification is a plus.
• Experience in assay development, qualification, validation, and implementation to support target candidate validation from non-GxP to GMP environments.
• Familiarity with applicable ICH regulations and multi-compendial guidelines related to method validation.
• Knowledge/hands-on experience in automation and liquid handlers are desirable but not required.
• Proactive, creative, ability to work effectively on cross-functional teams and positive attitude.
• Effective oral and written communication skills.
• Proven people leadership skills.

Additional Information:

• Travel - 5%
• Shift information – Day shift, 5-day/week
• Position 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$126,000 - $204,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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