About this role
Job title: Scientist I/II, tLNP Process Development
About the Role The tLNP Process Development (TCT) team within Biologics CMC is seeking a scientist to advance manufacturing process development for targeted lipid nanoparticles delivering mRNA therapeutics. The role focuses on full-scale process development from purified mRNA to purified tLNP bulk drug product, including encapsulation, bioconjugation, and tangential flow filtration, with emphasis on scalable, GMP-compatible operations. The work is hands-on lab-based and involves close collaboration with mRNA process development, drug product development, analytical development and cross-functional Biologics CMC teams to optimize processes and support clinical supply and regulatory submissions.
What You'll Do
- Independently design, execute and interpret critical experiments to understand unit operations (mRNA encapsulation, bioconjugation, tangential flow filtration) and scale them to commercial manufacturing batch size.
- Highly autonomous and productive in performing laboratory research or method development, requiring 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.
What We're Looking For
- Scientist I: BS in chemistry, colloidal science, or related field with 5+ years' industry experience or MS with 2+ years' industry experience. PhDs need not apply.
- Scientist II: 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 (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 and lipid chemistry is a plus.
- Demonstrated ability to independently design, execute, and interpret critical experiments; ability to learn new techniques; multitask; strong scientific writing and verbal communication skills.
Nice to Have
- Experience with lipid chemistry is a plus.
- Prior experience with gram-scale mRNA LNP scale-up.
- Strong publication/patent track record.
Compensation & Benefits
- 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.