Scientist II / Senior Scientist I, tLNP Process Development

BioSpace; North Chicago (IL); Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

AbbVie seeks a highly motivated scientist to join the tLNP Process Development team focusing on mRNA encapsulation, bioconjugation, and tangential flow filtration. The role emphasizes automation integration of hardware, software, and data workflows to increase throughput and process understanding.

The candidate will enable scale-up from lab to pre-clinical, clinical, and commercial manufacturing, while collaborating across Biologics CMC and Digital/Automation partners.

Qualifications

• BS, MS or PhD in Chemistry, Materials Science, Pharmaceutical Sciences, Bioengineering, Biomedical Engineering, Chemical Engineering, or equivalent.
• Senior Scientist I: BS 10+ years, MS 8+ years, PhD 0+ years of industry experience.
• Scientist II: BS 7+ years, MS 5+ years.
• Experience with LNP mixing technology in an academic or industrial setting.
• Experience with Bioconjugation.

Responsabilités

• Independently design, execute, and interpret critical experiments on mRNA encapsulation, bioconjugation, and tangential flow filtration.
• Scale up unit operations to commercial manufacturing batch size.
• Develop and implement automation solutions (custom and off-the-shelf).
• Apply AI tools for data capture, analysis, and predictive modeling.
• Mentor others and collaborate across cross-functional teams.

Connaissances

mRNA encapsulation

Bioconjugation

Automation

TFF (tangential flow filtration)

Laboratory process development

Formation

Chemistry

Chemical Engineering

Biomedical/Bioengineering

Outils

Ignition automation

LNP mixing equipment

TFF systems

Description du poste

Company Description

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, X and YouTube.

Job Description

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 team is responsible for the end-to-end manufacturing process from purified mRNA to purified tLNP bulk drug product, including encapsulating mRNA with lipid components to form LNPs, conjugating LNPs with a targeting moiety, and purifying the final tLNPs via 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 advances cutting-edge mRNA-based therapeutics.

Responsibilities

• Independently design, execute and interpret critical experiments to understand unit operations such as mRNA encapsulation, bioconjugation, and tangential flow filtration, and scale up these unit operations to commercial manufacturing batch size.
• Highly autonomous and productive in performing laboratory research or method development, requiring minimal direction from 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 tLNP 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.
• Proactively develop and implement innovative automation solutions (custom and off-the-shelf equipment).
• Apply AI tools for structured data capture, analysis, and predictive modeling.
• Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, and GMP compliance.
• Direct mentorship of others.

Qualifications

• BS, MS, or PhD degree in Chemistry, Material Science, Pharmaceutical Sciences, Bioengineering, Biomedical Engineering, Chemical Engineering, or equivalent.
• 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 LNP mixing technology in an academic lab, or industry experience with LNP drug product process development. For mRNA encapsulation, experience with systems such as impinging jet, coaxial jet, or multi-inlet vortex mixer is required.
• Possess thorough theoretical and practical understanding of mRNA encapsulation.
• Experience With Bioconjugation Is Required.
• 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.

Preferred Experience

• Experience scaling up LNP processes to gram-scale mRNA or above.
• Prior experience with automating existing experimental setups as well as new automation equipment and ecosystems, such as Ignition.

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 Company's sole and absolute discretion unless and until paid and may be modified at the Company’s 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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