Scientist II​/Senior Scientist mRNA

Company Description

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  Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.

Description:

• The targeted lipid nanoparticle (tLNP) process development team is seeking a highly motivated, talented, and innovative scientist to develop manufacturing processes for mRNA from linearized DNA plasmid into purified mRNA drug substance. The successful candidate will help advance understanding unit operations such as in vitro transcription (IVT), preparative chromatography, and tangential flow filtration, as well as scaling up lab processes into pre-clinical, clinical, and commercial scale manufacturing processes.
• Targeted lipid nanoparticles (tLNPs) represent a key new modality to enable the 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. The tLNP CMC team focuses on process development for tLNPs, including mRNA process development, tLNP process development, and formulation development.
• The mRNA process development team within TCT is responsible for developing the manufacturing process for mRNA from linearized DNA plasmid into bulk drug substance (purified mRNA). The process starts from IVT using the linearized DNA plasmid, purification of the crude IVT mixture, and tangential flow filtration. The mRNA process development team will work together with tLNP process development team, tLNP formulation team, and analytical development team.
  
  The team will also collaborate closely with various functions and Center of Excellence within Biologics CMC and Synthetic Molecule CMC departments.
• The end goal for mRNA process development team is to deliver a robust manufacturing process at commercial scale. This includes science‑based, hands‑on approaches in the lab to optimizing process parameters and understanding impact of process parameters on critical quality attributes. First‑principle based and statistical modeling can 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 supply and GMP clinical study supply from a manufacturing plant on‑site or at third‑party manufacturers.
  
  The team will also lead the tech transfer of commercial process into a commercial facility. Additionally, the team reviews appropriate sections of Common Technical Document (CTD) for regulatory submissions. Building strong cross‑functional relationships with internal and external partners is key to the team’s success. The work will contribute to cutting‑edge mRNA‑based therapeutics.

• Independently design, substance and interpret critical experiments to understand unit operations of mRNA process development with an emphasis on biocatalytic reactions and downstream purification of drug substance, and scale up these unit operations to commercial manufacturing batch size.
• Highly autonomous and productive in performing laboratory research or method development, requiring only minimal direction from or interaction with supervisor.
• May initiate new areas of investigation that are scientifically meaningful, reliable, and can be incorporated directly into a research or development program.
• Demonstrates high proficiency across a wide range of technologies relevant to mRNA process development.
• Formulate conclusions and design follow‑on experiments based on multidisciplinary data.
• Primary author of publications, presentations, regulatory documents and/or primary inventor of patents.
• Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, and GMP compliance.
• Direct mentorship of others.

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