Senior Scientist I – II, Analytical R&D (Lipids SME) Full-time

Lipids Sme Position

The analytical development group within the targeted lnp (tlnpcmc) team at abbyvie is dedicated to advancing state-of-the-art analytical capabilities for msg-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 tlnpcmc 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 tlnpcmc medicines to patients.

as a lipids sme within the analytical development team of abby's targeted lnp (tlnpcmc) 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 tlnpcmc. 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 rd 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 tlnpcmc drug product
• supporting formulation and manufacturing by ensuring consistent lipids quality
• design experiments to understand and characterize lipids degradation pathways in the final tlnpcmc drug product
• train and mentor junior scientists in lipids related analytical methodologies
• stay current on innovations, regulatory requirements, and industry best practices for tlnpcmc 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 abby 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 cmos or contract testing labs
• hands-on experience with additional analytical techniques relevant to msg or lnp analysis is considered a plus
• working knowledge of biosafety, data integrity, and compliance requirements for gxpregulatd 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