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

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 AbbVies 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. 

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 

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

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