Senior Scientist II - Principal Scientist , Analytical R&D; Bioassay

Company Description

About Abb Vie

Abb Vie'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 Abb Vie, please visit us at  Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.

About the Team:

The Analytical Development group within the Targeted LNP (tLNP) CMC Team at Abb Vie 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 Abb Vie’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 expression 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.

• 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 Abb Vie safety, quality and regulatory policies and government regulations.

• 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…