Scientist II Senior Scientist I, mRNA Process Development

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 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 teams 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 :

*Level is determined based on years of experience and education

• 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

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future. 

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

• This job is eligible to participate in our short-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable 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. 

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Work :

No

Employment Type :

Full-time