Advisor/Sr. Advisor - Process Chemistry

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. 

Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Lilly’s Cell and Gene Therapy (CGT) organization is advancing a growing pipeline of cell and gene therapy products committed to developing groundbreaking therapies for diseases that current approaches cannot address.

 

Position Summary:

We are seeking an exceptional Advisor or Sr. Advisor, to join the lipid process chemistry team. The candidate will support proprietary lipid process chemistry development, characterization, technology transfer, and manufacturing operations for Lilly’s Lipid Nanoparticle Drug Products. The candidate will work as part of a cross functional team to complete late-stage process development activities requiring collaboration across the Lilly network as well as with external contract development laboratories and manufacturing organizations (CDMOs). This role will provide day-to-day technical support for that work: defining experimental scope, reviewing and interpreting data, troubleshooting process issues, and capturing outcomes in clear, inspection-ready technical documentation. The ideal candidate will have a strong foundation in small molecule and lipid synthesis and purification, experience working with CDMOs, and the ability to translate CDMO-generated data into conclusion-driven reports and regulatory content. Furthermore, the candidate will possess strong oral and written communication capabilities, demonstrate excellent organization, collaboration, and interpersonal skills, and be adept at problem solving in a fast-paced environment.

 

Responsibilities:

Process chemistry development

• Provide technical oversight of CDMO process development for proprietary lipids including route scouting, reaction optimization, purification development, and scale-up.
• Review proposals and track progress against technical objectives, timelines, and deliverables.
• Provide scientific guidance and troubleshooting to CDMO scientists on day-to-day chemistry challenges.

 

Process characterization

• Apply risk assessment, design of experiments (DoE), and QbD principles to identify critical process parameters, critical quality attributes, and material specifications; support control strategy development.
• Partner with analytical development on impurity profiling and on the analytical methods supporting lipid characterization.
• Independently draft conclusion-driven development and characterization reports from protocol objectives and CDMO-generated data
• Maintain traceable, inspection-ready source documentation supporting regulatory submissions, process knowledge management, and lifecycle documentation requirements.

 

Technology transfer

• Author and review technology transfer packages for transfers between development and cGMP manufacturing, and between CDMOs.

 

Manufacturing support

• Provide technical support for cGMP manufacturing campaigns, including review of master and executed batch records, deviations, change controls, and investigations.
• Serve as Person-in-Plant during critical engineering and GMP runs as needed.
• Collaborate with Quality, Analytical, Formulation/Drug Product, and Supply Chain so that lipid raw materials integrate successfully into LNP drug product manufacturing.

 

Technical documentation

• Under the direction, author and review CMC content on custom raw materials (Lipids) for regulatory submissions (IND/IMPD/CTA) and responses to health authority questions.

 

Basic Requirements:

• PhD, MS, or BS degree in organic chemistry, chemical engineering, or a related scientific field including:
  • PhD with 2+ years of process chemistry experience
  • M.S. with 6+ years of process chemistry experience
  • B.S. with 8+ years of process chemistry experience
• Hands-on experience in multi-step organic synthesis, scalable purification, and analytical characterization (NMR, LC-MS, HPLC, HPLC-CAD) of lipids or small molecules.
• Experience working on process development, technology transfer, or clinical supply; experience working with CDMOs strongly preferred.
• Working knowledge of cGMP documentation standards, and ICH Quality guidelines relevant to process development and manufacturing.
• Strong written and verbal communication skills, with demonstrated ability to author technical reports.
• Proficiency in MS Word and Excel; experience with at least one Quality Management System platform (Veeva Vault, Documentum, or similar)
• Attention to detail, critical analysis of data and reports, and troubleshooting abilities. Self-motivated and excited to take on new challenges.

 

Additional Preferences:

• Experience with lipid or excipient synthesis and scale-up supporting RNA/LNP modalities.
• Experience with process characterization, including risk assessments, DoE, process performance evaluation, and late-stage CMC documentation practices strongly preferred.
• Experience authoring CMC sections of regulatory submissions or supporting health authority interactions.
• Experience with statistical and DoE software (e.g., JMP).

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

$157,500 - $231,000

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.

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