Scientist II / Senior Scientist I, mRNA Process Development Full-time

Scientist, mRNA Process Development

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.

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 Excellences 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.

Responsibilities:

• 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.

Qualifications:

• Senior Scientist I: BS with 10+ years', MS with 8+ years', and PhD with 0+ years' industry experience.
• Scientist II: BS with 7+ years', MS with 5+ years' industry experience.
• Experience with mRNA synthesis and purification in an academic lab, or industry experience with mRNA drug substance process development
• Possess thorough theoretical and practical understanding of IVT and downstream purification, including chromatographic separations and tangential flow filtration.
• Demonstrated ability to independently design, execute, and interpret critical experiments to answer scientific questions
• Demonstrated ability to learn, understand, and master new experimental techniques
• Ability to multitask and work within timelines
• Demonstrated scientific writing skills and strong verbal communication skills

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

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.