Advisor - Mixed Modality (Oligonucleotide) Scientist - Process Translation and Execution
PharmaBiotechClinical ResearchQuality Assurancegmpemacroraveinform
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 seeking passionate and agile scientist to join the PTE team and help bring the Lilly Medicine Foundry’s vision to life. Responsibilities The Mixed Modality (Oligonucleotide) Advisor sets technical strategy and direction for oligonucleotide manufacturing process transfers from development laboratories to pilot plant operations, including kilo-scale and isolator production environments, across multiple programs. This role shapes the Foundry's approach to early-phase cGMP manufacturing of gram to kilogram quantities of API for clinical trial supply, and serves as the site's recognized technical authority on oligonucleotide process transfer. Set strategy and technical direction for oligonucleotide process transfers across programs, ensuring scalability and process fit to plant. Serve as the escalation point for complex troubleshooting and technology adoption decisions. Define the scale-up approach for synthesis and purification methods coming out of early-phase process R&D, shaping how the function evaluates and adopts new methods. Serve as the site's technical authority on oligonucleotide unit operations, including solid phase synthesis, preparative chromatography, TFF, and lyophilization. Set standards and guide other scientists' technical decisions. Partner with safety and process engineering leadership to shape procedure evaluation standards and approve high-risk or novel procedures. Translate analytical data into strategic technical recommendations for program and site leadership. Represent process chemistry and technical challenges to senior leadership and cross-functional stakeholders, influencing program-level decisions. Set the standard for plant readiness assessment across synthesis, cleavage, purification, TFF, and lyophilization at the Lilly Medicine Foundry, and guide teams through familiarization execution. Establish the framework for use-tests and Definitive Lab Trials used to confirm plant readiness across programs. Own the technical quality and consistency of documentation practices, including tech transfer plans, SOPs, batch records, campaign summary reports, and deviation reports, across the function. Drive process improvement strategy, identifying where new technologies or procedures should be adopted site-wide. Provide technical leadership on complex process investigations and CAPAs. Serve as a key cross-functional partner to CMC, Product R&D, Manufacturing, and Quality leadership. Mentor principal and senior scientists on complex technical problems, and inform training standards for PTE. Basic Requirements: B.S., M.S., or Ph.D in Chemistry, Biochemistry, Chemical/Biochemical Engineering, or a related discipline. B.S. with 20+ years, M.S. with 15+ years, or Ph.d with 2+ years of experience in Oligonucleotide Product/Process Development, Manufacturing Technical Services, or related functional roles. 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. <l
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