Principal Scientist I, Analytical Development Lead (tLNP CMC)

About the role

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.

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 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.

Qualifications

• 12 (MS), or 6 (Ph.D.) years related industry experience.
• Demonstrated expertise in analytical method development for biologics, with strong hands-on experience in characterization methods, capillary electrophoresis and HPLC.
• Experience supporting biologics CMC development, QC method qualification/validation, and method transfer.
• Proven ability to interpret complex data, solve technical problems, and propose innovative scientific solutions.
• Experience contributing to regulatory submissions, including quality and characterization sections, and responding to health authority questions.
• Ability to supervise and mentor other scientists; and to coordinate testing work at internal and external laboratories.
• Working knowledge of 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
• Self-motivated, hard-working, detail-oriented individual able to work in a fast-paced team environment.