Senior Scientist II – Principal Scientist I, Analytical R&D (Bioassay) Full-time

Bioassay Sme

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.

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

As a Bioassay SME within the Analytical Development team of AbbVie's Targeted LNP (tLNP) CMC organization, you will be a technical leader for the deployment, optimization, and qualification of bioassays that measure the function and potency of next-generation mRNA-LNP therapeutics. You will ensure that all critical quality attributes related to bioactivity are robustly assessed, allowing the delivery of innovative, high-quality genetic medicines to patients. The successful candidate will have hands-on analytical method development experience for ELISA and cell-based potency assays (e.g., CAR expression/function, T-cell activation assays, and cytokine expressions assays, among others). 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 Affairs.

Responsibilities

Responsibilities include:

• Effectively function as a principal research scientist, generating original technical ideas and research or development strategies.
• Lead tech transfer, implementation and lifecycle management of cell-based potency assays (e.g., CAR expression/function, primary T cell activation assays, etc.).
• Spearhead the optimization and troubleshooting of in vitro functional assays such as CAR surface staining by flow cytometry, and ELISA for protein and cytokine expression.
• Generate new scientific proposals and lead those efforts. Anticipate and critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies.
• 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.
• 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

Qualifications include:

• Senior Scientist II: Analytical Chemistry degree (or related field). BS with 12+ years', MS with 10+ years', and PhD with 4+ years' industry experience.
• Principal Scientist I: Analytical Chemistry degree (or related field). BS with 14+ years', MS with 12+ years', and PhD with 6+ years' industry experience.
• Direct experience developing, qualifying, and transferring potency and functional bioassays for RNA/DNA therapeutics, nanoparticles, cell therapy, or gene-modified cell products.
• Hands-on expertise analyzing mRNA translation and protein expression in both immortalized and primary cell types, including multi-color flow cytometry and high-content imaging.
• Experience with DOE/statistical approaches for robust assay development, reference standard management, and functional assay lifecycle (including parallel line analysis and curve fitting, equivalency protocols).
• Ability to supervise and mentor other scientists; and to coordinate bioassay work at external CDMOs or contract testing labs.
• Working knowledge of biosafety, data integrity, and compliance requirements for GxP-regulated bioassay testing.
• Strong presentation and communication skills with the ability to explain data, controls, and risk assessments to technical and non-technical audiences.
• Demonstrate creative 'out of the box' thinking to solve difficult problems.

Additional Information

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

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.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.