Senior Scientist I - II, Analytical R&D (Stability Coordinator)

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

About the team: 

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: 

AbbVie’s Targeted LNP (tLNP) CMC Analytical Development group is seeking a Stability Coordinator to oversee the release and stability programs supporting clinical development of mRNA-LNP medicines. In this role, you will coordinate all aspects of stability testing with external CDMOs and internal teams, ensure the integrity of routine product release and stability data, lead investigations and coordinate technical troubleshooting when analytical issues arise. Additionally, the candidate must be able to 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.  

Responsibilities:

• Serve as the primary point of contact for stability and release testing of tLNP drug substance and drug product at external CDMO partners.
• Manage and monitor routine release and stability studies for DS and DP, including review of assay performance.
• Lead investigations into out-of-specification or atypical stability or release results; provide analytical troubleshooting, coordinate confirmatory testing, and drive root cause analysis.
• Compile and trend stability data, contributing to shelf-life assignments, comparability studies, and regulatory filings.
• Collaborate with analytical method owners, QA, Regulatory, and external partners to identify, communicate, and resolve analytical method and data issues.
• Track record of continuous improvement in analytical or stability programs, such as driving assay harmonization, implementing new technologies, or increasing efficiency and compliance.
• Strong project management capabilities, including timeline planning, risk mitigation, and proactive communication with internal and external stakeholders.
• Embraces the ideas of others, nurtures innovation and manages innovation to reality.
• Raises the bar and is never satisfied with the status quo.
• Understand and comply with AbbVie safety, quality and regulatory policies and government regulations. 

Qualifications

• Senior Scientist I: Analytical Chemistry degree (or related field). BS with 10+ years', MS with 8+ years', and PhD with 0+ years' industry experience. 
• Senior Scientist II: Analytical Chemistry degree (or related field). BS with 12+ years', MS with 10+ years', and PhD with 4+ years' industry experience. 
• Demonstrated experience working with or managing CDMOs for analytical or stability programs.
• Direct experience overseeing stability programs for advanced biologics, (oligonucleotide, or nanoparticle-based products preferred).
• Demonstrated expertise in protocol design, data trending and evaluation, shelf-life justification, and authoring CMC regulatory documents related to stability.
• Proven ability to manage outsourced analytical work, including change control, deviation investigations, and