Director, Oligonucleotide CMC & Process Chemistry

BioSpace; Indianapolis (IN); On-site; USD 149,000 - 257,000; Full time

Job summary

Lilly is seeking a highly experienced scientist to lead the CMC strategy for oligonucleotide therapeutics in the Synthetic Molecule Design and Development organization. You will drive development, tech transfer, and regulatory submissions across internal and external manufacturing partners, delivering robust processes for clinical and commercial supply.

The role emphasizes collaboration, innovation in synthesis, and leadership through ambiguity within a world-class R&D environment at Lilly's

Qualifications

• PhD or MS with extensive industry experience in synthesis, oligonucleotides, solid-phase synthesis, CMC.
• Experience in development and CMC including quality and regulatory interactions.
• Experience with tech transfer of processes into manufacturing operations.

Responsibilities

• Lead CMC activities to support clinical trials, product commercialization, and regulatory submissions.
• Collaborate with internal CMC networks to deliver materials and documentation for trials.
• Develop and apply impurity control strategies aligned with regulatory climate.

Skills

Oligonucleotide CMC

Technical leadership

Process development

Regulatory submissions support

Cross-functional collaboration

Publication record

Synthesis chemistry

Education

PhD in a relevant scientific discipline

MS in a relevant scientific discipline

Tools

Automated reactor platforms

Purification technologies

Job description

Lilly is seeking a highly experienced scientist to lead the CMC strategy for oligonucleotide therapeutics in the Synthetic Molecule Design and Development organization. You will drive development, tech transfer, and regulatory submissions across internal and external manufacturing partners, delivering robust processes for clinical and commercial supply.

The role emphasizes collaboration, innovation in synthesis, and leadership through ambiguity within a world-class R&D environment at Lilly's