Senior Scientist I - II, Analytical R&D (Lipids SME)

AbbVie • North Chicago, IL

1d

About The Position

Group Overview: The Analytical Development group within the Targeted LNP (tLNP) CMC Team at AbbVie is dedicated to advancing state-of-the-art analytical capabilities for mRNA-lipid nanoparticle therapeutics. Our team provides critical support across drug substance (DS) and drug product (DP) manufacturing, drug product formulation, and the development and implementation of robust analytical methodologies to ensure the quality, safety and integrity of tLNP genetic medicines. We leverage advanced biophysical, separations, and mass spectrometry techniques to deeply characterize intact LNP particles. We foster close collaborations with cross-functional colleagues in CMC, drug product formulation, and external partners, and are currently growing a world-class team of scientists who will be instrumental in building and deploying the analytical toolbox necessary to deliver high-quality, innovative tLNP medicines to patients. Position Description: As a Lipids SME within the Analytical Development team of AbbVie’s Targeted LNP (tLNP) CMC organization, you will be a technical leader for the development, optimization, and qualification of the analytical methods to characterize and control lipid components used in tLNP. The successful candidate will ideally possess experience in lipids control strategies and have practical expertise in developing analytical methods for lipid quantitation, purity evaluation, and identification of impurities or degradation products. Additionally, the candidate must foster productive collaborations within the global Analytical CMC organization and with R&D cross-functional partners such as Discovery, Pre-Clinical Safety, Process Chemistry, Process Engineering, Drug Product Development, and Quality Assurance and CMC-Regulatory Affairs.

Requirements

• Analytical Chemistry degree (or related field). BS with 10+ years', MS with 8+ years', and PhD with 0+ years' industry experience.
• Analytical Chemistry degree (or related field). BS with 12+ years', MS with 10+ years', and PhD with 4+ years' industry experience.
• Demonstrated understanding of the lipids structure and possible degradation pathways
• Demonstrated understanding of the lipids manufacturing process and critical quality attributes of lipids to be monitored
• Demonstrated capability to design experiments to understand lipids degradation pathways and establish analytical methods to monitor degradants
• Extensive hands-on experience in analytical techniques for lipids and LNPs (e.g., LC-CAD, LC-MS, spectroscopy)
• Direct experience developing, qualifying, and transferring analytical methods
• Ability to coordinate and help trouble shoot analytical methods at external CDMOs or contract testing labs
• Working knowledge of biosafety, data integrity, and compliance requirements for GxP-regulated testing
• Strong presentation and communication skills with the ability to explain data to technical and non-technical audiences
• Demonstrate creative 'out of the box' thinking to solve difficult problems

Nice To Haves

• Hands-on experience with additional analytical techniques relevant to mRNA or LNP analysis is considered a plus

Responsibilities

• Effectively function as the lead subject matter expert for analytical methods related to lipid quantitation, purity assessment, and identification of impurities or degradation products.
• Develop, optimize, validate, and implement analytical methods for lipid characterization and quality control
• Develop analytical control strategies for individual lipid components as well as for the lipid components in the final tLNP drug product
• Supporting formulation and manufacturing by ensuring consistent lipids quality
• Design experiments to understand and characterize lipids degradation pathways in the final tLNP drug product
• Train and mentor junior scientists in lipids related analytical methodologies
• Stay current on innovations, regulatory requirements, and industry best practices for tLNP lipid components quality control
• Generate new scientific proposals and lead those efforts
• Demonstrated ability to collaborate effectively with team members and a willingness to continuously learn new techniques to enhance and advance the analytical capabilities of the program
• Demonstrate scientific initiative and creativity in research or development activities and maintain a high level of productivity in the lab
• Embraces the ideas of others, nurtures innovation and manages innovation to reality
• Understand and comply with AbbVie safety, quality and regulatory policies and government regulations

Benefits

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree