Senior Scientist II Principal Scientist I, Analytical R&D (Bioassay)

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 AbbVies 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:

• 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 :

• 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 :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• 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 postingbased 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 orless 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. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commissionincentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paidand may be modified at the Companys sole and absolute discretion consistent with applicable law. 

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. 

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Work :

No

Employment Type :

Full-time