Advisor RNA-LNP Process Development BR&D
Eli Lilly and Company
Boston, MA (In Person)
$205,350 Salary, Full-Time
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Job Description
Roles and Responsibilities:
Build process capabilities for lab scale, early phase clinical scale, and scale up technologies for RNA-LNPs and other parenteral drug products. Support the development of portfolio assets (particularly RNA-LNPs), including assessing and mitigating process risks during scale-up through an understanding of in-process and final product critical quality attributes. Anticipate and manage increased workload during scale-up and GMP readiness phases. Work with project management and other technical leaders to execute complex tech transfer challenges across sites, including both internal and external manufacturing organizations. Help oversee supply chain readiness and ensure integration of novel excipients into regulatory filing packages. Implement processes to deliver drug product material for clinical trials and support generating data required for regulatory filings, including addressing CMC regulatory questions. Ensure consistency in technical deliverables and documentation across transfers. Partner with analytical colleagues and aid in the transfer and installation of analytical methods to assess developability of portfolio molecules, including familiarity with acquisition and analysis of chromatography methods (e.g., SEC, HPLC, UHPLC methods).Cross-Functional Collaboration:
Represent the product research & development organization on project teams. Partner with genetic medicines discovery, synthetic chemistry, toxicology, ADME, analytical, and device to support drug delivery, formulation, or process efforts.External Engagement:
Establish and leverage strategic relationships with academic and industry partners to accelerate and access emerging innovation.Innovation:
Drive a strong innovation agenda for the team leading to publications, presentations and industry wide influence. Leverage these innovations to advance the Lilly portfolio. This is a full-time onsite role (five days per week) in Boston, MA.Basic Qualifications:
Ph.D. in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or a related field. 0-5 years of prior experience in nanoparticle formulations, oligonucleotide and/or gene delivery development programs, parenteral formulation, or process development. Experience with process development of RNA-lipid nanoparticle and/or oligonucleotide formulations. Familiarity with engineering fundamentals towards designing and optimizing manufacturing processes, or drug delivery platforms including RNAs and LNPs.Additional Skills and Preferences:
Hands-on experience working with process equipment from lab to pilot scales is preferred. Previous experience with regulatory submissions of RNA-based therapies is preferred. Self-directed and highly motivated individual who wants to learn new techniques while continually pursuing research and publication goals. Excellent communicator (oral and written) with presentation experience, along with a strong publication record. Proficient in data analysis and reporting. Final job level (Advisor or Senior Advisor) will be based on the selected candidate's experience and qualifications and determined at the hiring manager's discretion. 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 (careers.lilly/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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $166,500 - $244,200 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 Company Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to "take what you find here and make it better and better." More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. Company info Location 893 S Delaware St Indianapolis Indiana 46285 United StatesSimilar remote jobs
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