Mixed Modality (Oligonucleotide) Scientist

Initial Therapeutics, Inc.; Lebanon (IN); On-site; USD 68,000 - 174,000; Full time

Job summary

Lilly is seeking a highly skilled scientist to guide the transfer of oligonucleotide manufacturing processes from development to pilot plant and early cGMP production for clinical supplies. You will collaborate across CMC, Product R&D, Manufacturing and Quality to ensure plant readiness and process robustness.

The role requires 7+ years (MS) or 10+ years (BS) in oligonucleotide development or related functions, with strong data analysis and cross-functional leadership skills.

Qualifications

• B.S. or M.S. in Chemistry, Biochemistry, Chemical/Biochemical Engineering, or a related discipline.
• B.S. with 10+ years or M.S. with 7+ years of experience in Oligonucleotide Product/Process Development, Manufacturing Technical Services, or related functional roles.
• Qualified applicants must be authorized to work in the United States on a full-time basis; Lilly will not sponsor work authorization or visas.

Responsibilities

• Oversee successful transfer of new oligonucleotide processes from development to manufacturing with scalability.
• Assess and scale-up synthesis and purification methods from early phase process development labs.
• Familiarity with oligonucleotide procedures such as solid phase synthesis, preparative chromatography, TFF, and lyophilization.
• Evaluate procedure safety in collaboration with safety group and process engineering.
• Analyze analytical data to make fact-based decisions.
• Lead plant readiness activities for synthesis, cleavage, purification, TFF, and lyophilization at the Lilly Medicine Foundry.

Skills

Oligonucleotide process development

Cross-functional collaboration

Data analysis

Written and verbal communication

Root cause analysis

Project leadership

Supervisory experience

Process transfer

Scale-up experience

Education

B.S. in Chemistry/Biochemistry/Engineering

M.S. in Chemistry/Biochemistry/Engineering

Tools

HPLC/UPLC

LC-MS

GC

TFF

Lyophilization

Job description

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 unite caring with discovery to make life better for people around the world. We are a global healthcare leader, headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization and Position Overview

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development, Lebanon, Indiana. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

The Process Translation and Execution (PTE) team translates API/DS process knowledge into clinical supply readiness, oversees technology transfer, implements phase-appropriate control strategies, and ensures right-first-time clinical manufacturing for a variety of modalities, including synthetic molecules, biologics, peptides, oligonucleotide, and bioconjugates (ADC, ARC, etc.) Through cross-functional collaboration, PTE influences process design, revolutionizes clinical manufacturing, builds capabilities in emerging technologies and aligns with corporate and Lilly Research Labs (LRL) goals, drives scientific excellence and innovation to accelerate manufacturing advancements and propels the site toward long-term business success.

In the Foundry Construction and Project Delivery/Startup Phase (2025 to 2028), roles will be fluid and dynamic as we build a new organization, design and implement the necessary systems and business processes required to enable operational readiness, support the project delivery, and build the site culture. Success will require significant collaboration, creativity, and resilience as the Lilly Medicine Foundry transitions from design to startup and ultimately to steady-state operations and continuous improvement. This period presents a unique opportunity for learning, growth, and making a lasting impact.

We are seekingpassionate and agile scientist to join the PTE team and help bring the Lilly Medicine Foundry’s vision to life.

Responsibilities

In this role, the Mixed Modality (Oligonucleotide) Principal Scientist will be responsible with evaluating and facilitating the transfer of oligonucleotide manufacturing processes, under appropriate supervisory guidance, from development laboratories to pilot plant operations (including kilo-scale and isolator production environments). This enables the successful transition to early-phase cGMP manufacturing of grams to kilogram quantities of API required for clinical trial supply.

• Oversee the successful transfer of new oligonucleotide processes from development to manufacturing; ensure scalability and process fit to plant; apply scientific knowledge to troubleshoot production issues and implement new technologies or procedures.
• Assess and scale-up synthesis and purification methods from early phase process research and development labs
• Familiarity with performing oligonucleotide procedures, such as solid phase synthesis, preparative chromatography, TFF, & lyophilization.
• Evaluate the safety of the incoming procedures in collaboration with the safety group and process engineering.
• Analyze analytical data to make fact-based decisions.
• Efficient with summarizing and presenting chemistry and challenges.
• Lead familiarization executions to ensure plant readiness of process steps including synthesis, cleavage, purification, TFF, & lyophilization at the Lilly Medicine Foundry.
• Perform use-tests of key in-process materials and document Definitive Lab Trials of processes to confirm plant readiness.
• Documentation:Author, review technical documents, including tech transfer plan, standard operating procedures (SOPs), batch records, campaign summary reports, and deviation reports.
• Process improvement:Apply scientific knowledge to identify areas for improvement and implement new technologies or procedures.
• Lead process-related investigations, assess deviations, and support CAPAs; collaborate closely with CMC, Product R&D, Manufacturing, and Quality teams; provide on-floor support for critical operations and train/mentor junior scientists and technicians in PTE activities.

Basic Requirements:

• B.S. or M.S. in Chemistry, Biochemistry, Chemical/Biochemical Engineering, or a related discipline.
• B.S. with 10+ years or M.S. with 7+ years of experience in Oligonucleotide Product/Process Development, Manufacturing Technical Services, or related functional roles.
• 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

Additional Preferences:

• Strong knowledge of oligonucleotide process (upstream or downstream), including synthesis, cleavage & deprotection, chromatography, conjugation, and aseptic processing.
• Proven ability to analyze data, perform root cause analysis, and resolve complex technical challenges; solid understanding of biopharmaceutical manufacturing principles and cGMP requirements.
• Demonstrated success in cross-functional, dynamic, and matrixed environments; excellent written and verbal communication skills for technical report writing, presentations, and team collaboration.
• Previous experience leading small projects, coordinating activities, and managing timelines; supervisory experience of junior scientists or technicians highly preferred.
• Proactive engagement with external innovation and industry trends; proven ability to champion accelerated adoption of transformative technologies in manufacturing environments.
• Experience with oligo synthesis and purification techniques used for developing and scaling-up process reactions. Experience using process chemistry concepts is a plus.
• Comfortable working with larger sized reactors and preparative columns, TFF, and related-equipment.
• Highly motivated, able to learn rapidly, and demonstrates strong attention to detail.
• Has experience creating batch records and conducting scale-up experiments according to those records.
• Ability to prioritize multiple activities and manage ambiguity.
• Experience with a variety of analytical techniques: HPLC/UPLC, LC-MS, GC, etc.
• Process quantification and acquiring mass balance for products and by-products.
• Communication skills:Excellent written and verbal communication skills for technical report writing, presentations, and effective collaboration across teams
• Problem-solving skills:Proven ability to analyze data, perform root cause analysis, and resolve complex technical challenges.

Other Information:

• Initial location at Lilly Technology Center, Indianapolis and/or Parkwood West
• Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.
• Limited domestic and international travel (< 5%) may be required for this role
• Role requires ability to work in manufacturing and laboratory environments

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

#WeAreLilly

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

$67,500 - $173,800

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