Job DescriptionOverview:
Targeted lipid nanoparticles (tLNPs) are a key emerging modality for the effective delivery of mRNA therapeutics. The tLNP CMC Team (TCT), a newly formed group within Biologics CMC, Development Sciences, R&D, is seeking a scientist to join its tLNP Process Development team.
This team is responsible for the full manufacturing process from purified mRNA to purified tLNP bulk drug product: encapsulating mRNA with lipid components to form LNPs, conjugating LNPs with a targeting moiety, and purifying the final tLNPs via tangential flow filtration. The role focuses entirely on manufacturing process development, not on mRNA sequence design, lipid structure, or targeting moiety design.
The team's mandate spans the full pharmaceutical development lifecycle: optimizing process parameters and their impact on critical quality attributes, producing non-GMP pre-clinical and GMP clinical supply, leading commercial tech transfer, and authoring relevant CTD sections for regulatory submissions. Science-based, hands-on lab work is central, with first-principles and statistical modeling applied where appropriate.
Success in this role depends on close collaboration with the mRNA process development, drug product development, and analytical development teams, 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 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 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.
- Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, and GMP compliance.
Qualifications- Scientist I: Trained in chemistry, colloidal science, or a related field. BS with 5+ years' or MS with 2+ years' industry experience. PhDs need not apply.
- Scientist II: Trained in chemistry, colloidal science, or a related field. BS with 7+ years' or MS with 5+ years' industry experience. PhDs need not apply.
- Industry experience in tLNP process development (mRNA encapsulation, conjugation, ultrafiltration/diafiltration) is highly preferred.
- For mRNA encapsulation, experience with systems other than microfluidics, such as impinging jet, coaxial jet, or multi-inlet vortex mixer is required.
- Experience scaling up LNP processes to gram-scale mRNA or above is highly preferred.
- Possess thorough theoretical and practical understanding of mRNA encapsulation
- Experience with bioconjugation is a plus
- Experience with lipid chemistry is a plus
- 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 InformationApplicable 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.
