Lilly
healthcare
ScientificDirector,ProcessChemistryOligonucleotides
“Scientific Director, Process Chemistry - Oligonucleotides at Lilly. Skills: oligonucleotide CMC expertise, synthetic organic and nucleic acid chemistry, impurity control strategies, route design, process development, scale-up, automated reactor platforms, purification technologies, CMC networks, external chemistry innovations, chemical design, mechanism-based problem solving, total synthesis, methodology development, oligonucleotide synthesis. Bring extensive oligonucleotide CMC expertise to SMD”
What You'll Achieve.
deliver breakthrough medications; develop creative solutions to support communities through philanthropy and volunteerism; help bring the next generation of life-changing medicines to patients; support emerging synthetic needs across the rapidly evolving Lilly Genetic Medicines (LGM) portfolio; lead CMC activities to support clinical trials, product commercialization, and regulatory submissions of oligonucleotide therapeutics; support oligonucleotide synthesis, tech transfer, and campaign execution; deliver robust processes for clinical and commercial supply; deliver materials and documentation for clinical trials and regulatory submissions; represent Lilly externally through presentations at symposia and consortia and publications in peer-reviewed journals; Contribute novel chemical design and mechanism-based problem solving (e. g. , total synthesis, methodology development, oligonucleotide synthesis), reflected in a peer-reviewed publication record
Industry & Context.
mechanism-based problem solving; address key CMC challenges
Position Local: Indianapolis, Lilly Technology Center-North (LTC-N), The physical demands of this job are consistent with a lab environment, Travel: 0 to 10%, work environment is in a laboratory environment
What They're Looking For.
Must Have
PhD in a relevant scientific discipline with 5+ years of relevant industry experience (synthesis, oligonucleotides, solid-phase synthesis, CMC), MS in a relevant scientific discipline with 8+ years of relevant industry experience (synthesis, oligonucleotides, solid-phase synthesis, CMC), Experience within the pharmaceutical sector: active ingredient development and associated formulated developing chemical processes from mid-development (proof of concept) through commercialization, Experience in development and CMC including quality and regulatory interactions, Experience with tech transfer of processes into manufacturing operations
Nice to Have
Prior experience in validation activities, interpersonal skills and a collaborative working style, Demonstrated initiative and appropriate risk-taking, Demonstrated technical proficiency and ability to create ideas for future work plans, technical skills that deliver business value, Knowledge and experience with management of a technical project, Demonstrated leadership capabilities, especially in a team environment, Ability to prioritize multiple activities and manage ambiguity, Ability to influence others to promote a positive work environment, Demonstrated success in persuasion, influence, and negotiation
What You'll Do.
Bring extensive oligonucleotide CMC expertise to SMDD and grow internal capability through coaching
and technical leadership across a diverse portfolio — complex single strands
and oligonucleotide conjugates (AOC and PRC)
Apply modern synthetic organic and nucleic acid chemistry to challenge existing methods
define new manufacturing technologies
and address key CMC challenges across the LGM portfolio
Develop and apply impurity control strategies aligned with the current global regulatory address CMC regulatory questions enabling clinical studies and marketing authorization applications
Provide technical leadership across route design
and scale-up — from laboratory plans through demonstration on development- and commercial-scale equipment
partnering with internal manufacturing (Lilly Medicine Foundry) and external CMOs to deliver robust processes for clinical and commercial supply
Demonstrate skills with automated reactor platforms and purification technologies and apply them across the oligonucleotide portfolio
Collaborate across internal CMC networks (Drug Product Delivery
and Regulatory) to deliver materials and documentation for clinical trials and regulatory submissions
Identify and integrate external chemistry innovations to complement internal represent Lilly externally through presentations at symposia and consortia and publications in peer-reviewed journals
Contribute novel chemical design and mechanism-based problem solving (e. g.
methodology development
oligonucleotide synthesis)
reflected in a peer-reviewed publication record
Lead through ambiguity and encourage initiative
and diverse perspectives across the team
How You'll Work.
Team & Collaboration
Collaborate across internal CMC networks (Drug Product Delivery, Project Management, Quality, Manufacturing, and Regulatory) to deliver materials and documentation for clinical trials and regulatory submissions; partnering with internal manufacturing (Lilly Medicine Foundry) and external CMOs to deliver robust processes for clinical and commercial supply; Collaborate with a growing team comprising chemists, analysts, and engineers focused on the development and optimization of existing methods and exploration of novel synthetic approaches to oligonucleotides and their conjugates
Communication Scope
presentations at symposia and consortia; publications in peer-reviewed journals
Process & Methodology
management of a technical project
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