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:

The Analytical Development group within Abb Vie’s 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 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.

• 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, Nano Sight 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.

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 Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

Abb Vie 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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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 www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.