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AbbVie Inc. in the United States seeks a scientist to join the tLNP Process Development team. You will advance mRNA-LNP process development, including encapsulation, bioconjugation, and tangential flow filtration (TFF).
The role emphasizes automation, data workflows, collaboration across Biologics CMC and Synthetic Molecule CMC, and advancing processes to pre-clinical and GMP scale. Mentorship and cross-functional teamwork are expected.
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. Follow @abbvie on LinkedIn,Facebook,Instagram,Xand YouTube.
Targeted lipid nanoparticles (tLNPs) represent a key new modality to enable effective delivery of mRNA. The tLNP chemistry, manufacturing, and control (CMC) team (TCT) is a newly formed group under Biologics CMC, Development Sciences, R&D. TCT focuses on process development for tLNPs, including mRNA process development, tLNP process development, and formulation development.
The tLNP Process Development team is seeking a highly motivated, talented, and innovative scientist with expertise in mRNA-LNP process development and an interest in laboratory automation. This teamis responsible forthe end-to-end manufacturing process from purified mRNA to purifiedtLNPbulk drug product, including encapsulating mRNA with lipid components to form LNPs, conjugating LNPs with a targeting moiety, and purifying the finaltLNPsvia tangential flow filtration (TFF).
The successful candidate will help advance fundamental understanding of tLNP unit operations, such as mRNA encapsulation, bioconjugation, and TFF, as well as scaling up lab processes into pre-clinical, clinical, and commercial scale manufacturing processes. The candidate will also apply automation expertise to integrate off-the-shelf and custom-built hardware, software, and data workflows into flexible experimental platforms that increase throughput, reproducibility, and process understanding.
The end goal for tLNP Process Development team is to deliver a robust manufacturing process at commercial scale. This includes science-based, hands-on approaches in the lab to optimize process parameters and understand the impact of process parameters on critical quality attributes. First-principle-based and statistical modeling will be applied where appropriate. Along the pharmaceutical development life cycle, the team will be responsible for successful production of non-GMP pre-clinical safety study supplies and GMP clinical study supplies from a manufacturing plant on site or at third party manufacturers. The team will also lead the tech transfer of commercial processes into a commercial facility. Additionally, the team reviews appropriate sections of Common Technical Document (CTD) for regulatory submissions.
Success in this role depends on close collaboration with the mRNA process development, drug product development, and analytical development, digital and automation partners, as well as cross-functional partners across Biologics CMC and Synthetic Molecule CMC. The work directly advancescutting-edgemRNA-based therapeutics.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company’ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
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https://www.abbvie.com/join-us/reasonable-accommodations.html