Principal Scientist I, Analytical Development Lead (tLNP CMC)

## Company Description **About AbbVie** AbbVie'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 AbbVie, please visit us at [www.abbvie.com](http://www.abbvie.com/). Follow @abbvie on [LinkedIn,](https://www.linkedin.com/company/abbvie/) [Facebook](https://www.facebook.com/AbbVieGlobal/), [Instagram](https://www.instagram.com/abbvie/), [X](https://twitter.com/abbvie) and [YouTube.](https://www.youtube.com/user/AbbVie) ## Job Description 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 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 an Analytical Lead within the Analytical Development team of AbbVie’s Targeted LNP (tLNP) CMC organization, you will be a cross-functional leader for scientific leadership in the development of advanced analytical methods to support tLNP characterization, process understanding, and product development. The successful candidate will independently develop innovative approaches and apply state-of-the-art electrophoresis and chromatography methods, serve as an analytical lead on development teams, and contribute to regulatory strategy and scientific innovation and coordinate testing with external manufacturing and testing organizations. This position also includes supervisory responsibilities, including leading and mentoring one or more scientists and supporting their performance and development. 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 a principal research scientist, generating original technical ideas and research or development strategies. - Represent the tLNP Analytical Research and Development Group as Analytical Lead on CMC development teams and a subject matter expert on cross functional project teams. - Supervise a team of one or more scientists and be accountable for the performance of the team. - Develop/optimize, qualify/validate, and transfer fit-for-purpose QC release and stability methods. Provide technical support and oversight for QC testing occurring at internal and external GMP laboratories. - Plan, author, and review regulatory submission documents, responses to health authority queries, technical reports, lab data, stability protocols/reports and method qualification/validation protocols. - 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 th…