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

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: 

The Analytical Development group within AbbVies Targeted LNP (tLNP) CMC Team advances best-in-class analytical capabilities to deeply characterize mRNA-lipid nanoparticle therapeutics. We play an instrumental role in ensuring the quality safety and efficacy of tLNP genetic medicines by leveraging advanced biophysical separation and mass spectrometry techniques. As a Particle Characterization Expert you will drive the development and implementation of robust characterization strategies for the intact drug product using a comprehensive suite of biophysical and analytical tools including DLS NTA AF4/MALS  TEM/CryoEM DSF/DSC and other relevant technologies. We are looking for diverse candidates with strong scientific experience to join the Analytical R&D team and can offer exciting and rewarding career opportunities for these candidates. 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.
• Develop optimize and execute characterization assays for the drug product (intact LNPs) including but not limited to particle size morphology aggregation and surface properties using platforms such as DLS NTA MALS TEM/cryoEM and CD.
• 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. 
• Strong technical background in analytical chemistry excellent analytical problem-solving skills. Capable of independently developing and troubleshooting analytical methods.
• Demonstrated expertise in troubleshooting optimizing and validating particle sizing and morphology methods (DLS NTA MALS CryoEM CD DSC) for complex nanoparticle or biologic products.
• Prior responsibility for designing and leading DOE or comparability studies assessing the impact of process and formulation variables on LNP particle attributes.
• Familiarity with critical quality attribute (CQA) setting and the regulatory expectations for LNPs and nanoparticle-based drug products preferred.
• Experience with method qualification and transfer to external CDMOs; ability to troubleshoot analytical issues remotely and coordinate investigations.
• Working knowledge of forced degradation studies and the ability to analyze stability-related changes in LNP size morphology aggregation or targeting moiety integrity.
• Strong data management and analysis skills including proficiency with relevant software for particle analysis (e.g. Malvern Zetasizer NanoSight NTA Astra cryoEM image processing related software).
• Knowledge of preclinical and clinical formulation development principles relevant to lipid nanoparticle (LNP) formulations - demonstrated industry experience strongly preferred.
• Familiarity with the role that physicochemical properties play in drug delivery and formulation design.
• Demonstrate creative out of the box thinking to solve difficult problems
• High-quality written and oral communication skills and ability to interact effectively with interdisciplinary scientists and engineers.

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 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. 

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 commission incentive 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 paid and 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