What are the responsibilities and job description for the Senior Scientist/Principal Scientist, RNA-LNP Formulation and Process Development position at BioSpace?
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
This position is responsible for designing and executing formulation and process development studies for RNA-lipid nanoparticle (RNA-LNP) drug products, and for supporting technology transfer and manufacture of early-phase clinical trial supplies for assigned projects. The scientist will work closely with other scientists as part of multidisciplinary teams driving product/process development as well as platform innovation, interacting with Discovery, API Development, Analytical Development, Bioproduct Research & Development, CT Operations, and Manufacturing.
Key Responsibilities
Plan, design, and execute experiments with increasing independence; analyze and interpret data and propose next steps. Manage multiple priorities and collaborate effectively across CMC functions and across the discovery-development interface.
Develop and scale LNP manufacturing processes, including rapid-mixing nanoprecipitation (e.g., microfluidic or impinging-jet mixing), buffer exchange, conjugation, tangential flow filtration (TFF), and sterile filtration.
Characterize relationships between process parameters and LNP critical quality attributes (e.g., particle size, polydispersity, encapsulation efficiency, RNA integrity, lipid content), using design of experiments and statistical approaches where appropriate.
Perform RNA-LNP characterization using methods such as dynamic light scattering (DLS), RiboGreen encapsulation assays, UPLC/HPLC lipid analysis, and RNA integrity methods (gel electrophoresis); interpret results in the context of product quality.
Keep abreast of relevant new technologies and help evaluate/implement new laboratory capabilities. Actively follow the scientific literature and bring forward new ideas and approaches to the team. Work closely with senior scientists, with growing independence, on platform innovation initiatives.
Present data at team meetings, internal technical forums, and external conferences as needed.
Support technology transfer of RNA-LNP formulations and manufacturing processes to internal or external (CDMO) sites for early-phase clinical trial (CT) manufacture, including preparation of transfer documentation and on-site support as needed.
Recognize technical issues and escalate them to the project lead or management in a timely manner.
Author technical reports, protocols, and development summaries; provide supporting data and technical input to CMC documentation when requested.
Support organizational initiatives as required (e.g., laboratory operations, equipment ownership, safety programs).
Interact with external partners (e.g., CDMOs, vendors, research collaborators) in support of project activities.
Train and mentor junior scientists, associates, and interns.
Ensure work is aligned with all relevant PR&D Development Quality, regulatory, and HSE requirements; maintain complete and timely laboratory records.
Approach technical challenges with curiosity and creative problem solving and be open to trying new methods rather than relying solely on established procedures.
Demonstrate good communication skills, the ability to follow procedures and instructions, and attention to detail; perform sample forecasting and retrieve and compile data from appropriate databases.
Educational Requirements
Bachelor's degree in chemical engineering, chemistry, pharmaceutical science, biomedical engineering, or a related field with 4 of relevant industry experience; OR
Master's degree in chemical engineering, chemistry, pharmaceutical science, biomedical engineering, or a related field
Hands-on experience formulating RNA-LNPs (e.g., mRNA, siRNA, or other nucleic acid payloads), including LNP preparation by rapid mixing and downstream processing (e.g., TFF, dialysis, sterile filtration).
Hands-on experience with RNA-LNP analytical methods and with interpreting the resulting data.
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1
Preferences
Demonstrated initiative and problem-solving ability, with evidence of generating new ideas, designing experiments to test them, and quickly learning new techniques.
Mechanistic understanding of process engineering principles (e.g., mixing and transport phenomena, unit operations, scale-down/scale-up) as applied to nanoparticle or parenteral drug products and familiarity with process analytical and characterization tools are highly desirable.
Experience scaling up LNP processes or supporting technology transfer to a clinical manufacturing site or CDMO.
Experience with additional RNA and LNP characterization methods (e.g., capillary electrophoresis for RNA integrity, nanoparticle tracking analysis, cryo-TEM, SAXS).
Experience working in a pharmaceutical or biopharmaceutical industry setting.
Experience in any of the following: targeted nanoparticles, process analytical technology (PAT), continuous manufacturing, alternative storage presentations for LNPs, scale-down models, mathematical modeling.
Track record of innovation (e.g., publications, patents, conference presentations, or introducing new methods or technologies into a laboratory).
Familiarity with working in a regulated environment (e.g., GMP awareness, good documentation practices).
Strong Oral And Written Communication Skills Are Essential.
Proficiency with standard computer and data-analysis tools. Experience with statistics/design of experiments, scripting, or data visualization is desirable.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$72,000 - $215,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
This position is responsible for designing and executing formulation and process development studies for RNA-lipid nanoparticle (RNA-LNP) drug products, and for supporting technology transfer and manufacture of early-phase clinical trial supplies for assigned projects. The scientist will work closely with other scientists as part of multidisciplinary teams driving product/process development as well as platform innovation, interacting with Discovery, API Development, Analytical Development, Bioproduct Research & Development, CT Operations, and Manufacturing.
Key Responsibilities
Plan, design, and execute experiments with increasing independence; analyze and interpret data and propose next steps. Manage multiple priorities and collaborate effectively across CMC functions and across the discovery-development interface.
Develop and scale LNP manufacturing processes, including rapid-mixing nanoprecipitation (e.g., microfluidic or impinging-jet mixing), buffer exchange, conjugation, tangential flow filtration (TFF), and sterile filtration.
Characterize relationships between process parameters and LNP critical quality attributes (e.g., particle size, polydispersity, encapsulation efficiency, RNA integrity, lipid content), using design of experiments and statistical approaches where appropriate.
Perform RNA-LNP characterization using methods such as dynamic light scattering (DLS), RiboGreen encapsulation assays, UPLC/HPLC lipid analysis, and RNA integrity methods (gel electrophoresis); interpret results in the context of product quality.
Keep abreast of relevant new technologies and help evaluate/implement new laboratory capabilities. Actively follow the scientific literature and bring forward new ideas and approaches to the team. Work closely with senior scientists, with growing independence, on platform innovation initiatives.
Present data at team meetings, internal technical forums, and external conferences as needed.
Support technology transfer of RNA-LNP formulations and manufacturing processes to internal or external (CDMO) sites for early-phase clinical trial (CT) manufacture, including preparation of transfer documentation and on-site support as needed.
Recognize technical issues and escalate them to the project lead or management in a timely manner.
Author technical reports, protocols, and development summaries; provide supporting data and technical input to CMC documentation when requested.
Support organizational initiatives as required (e.g., laboratory operations, equipment ownership, safety programs).
Interact with external partners (e.g., CDMOs, vendors, research collaborators) in support of project activities.
Train and mentor junior scientists, associates, and interns.
Ensure work is aligned with all relevant PR&D Development Quality, regulatory, and HSE requirements; maintain complete and timely laboratory records.
Approach technical challenges with curiosity and creative problem solving and be open to trying new methods rather than relying solely on established procedures.
Demonstrate good communication skills, the ability to follow procedures and instructions, and attention to detail; perform sample forecasting and retrieve and compile data from appropriate databases.
Educational Requirements
Bachelor's degree in chemical engineering, chemistry, pharmaceutical science, biomedical engineering, or a related field with 4 of relevant industry experience; OR
Master's degree in chemical engineering, chemistry, pharmaceutical science, biomedical engineering, or a related field
Hands-on experience formulating RNA-LNPs (e.g., mRNA, siRNA, or other nucleic acid payloads), including LNP preparation by rapid mixing and downstream processing (e.g., TFF, dialysis, sterile filtration).
Hands-on experience with RNA-LNP analytical methods and with interpreting the resulting data.
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1
Preferences
Demonstrated initiative and problem-solving ability, with evidence of generating new ideas, designing experiments to test them, and quickly learning new techniques.
Mechanistic understanding of process engineering principles (e.g., mixing and transport phenomena, unit operations, scale-down/scale-up) as applied to nanoparticle or parenteral drug products and familiarity with process analytical and characterization tools are highly desirable.
Experience scaling up LNP processes or supporting technology transfer to a clinical manufacturing site or CDMO.
Experience with additional RNA and LNP characterization methods (e.g., capillary electrophoresis for RNA integrity, nanoparticle tracking analysis, cryo-TEM, SAXS).
Experience working in a pharmaceutical or biopharmaceutical industry setting.
Experience in any of the following: targeted nanoparticles, process analytical technology (PAT), continuous manufacturing, alternative storage presentations for LNPs, scale-down models, mathematical modeling.
Track record of innovation (e.g., publications, patents, conference presentations, or introducing new methods or technologies into a laboratory).
Familiarity with working in a regulated environment (e.g., GMP awareness, good documentation practices).
Strong Oral And Written Communication Skills Are Essential.
Proficiency with standard computer and data-analysis tools. Experience with statistics/design of experiments, scripting, or data visualization is desirable.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$72,000 - $215,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Salary : $72,000 - $215,600