CMC Lead

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.

R7-R9

Shanghai, China

Lilly Catalyze360 is a comprehensive approach to enabling the early-stage biotech ecosystem by democratizing access to infrastructure, expertise, and resources. Through its interconnected pillars—Lilly Ventures, Lilly Gateway Labs, Lilly ExploR&D, and Lilly TuneLab—Catalyze360 strategically removes barriers that traditionally block bold science from becoming life-changing medicines, providing biotechs with flexible combinations of capital, physical lab space, R&D capabilities, AI/ML tools, and decades of enterprise learning.

Lilly ExploR&D is a team of drug discovery and development experts who partner with biotechs from discovery through clinical proof-of-concept, putting Lilly's industry-leading capabilities behind their missions. We provide flexible support—from strategic consulting to full program execution—making it faster, easier, and more capital-efficient for innovators to transform bold science into life-changing medicines.

Technical Leadership: Provide CMC strategy, leadership and technical oversight for drug substance synthesis/expression, drug product formulation, and analytical method development for programs across multiple modalities. Ensure scientific rigor and regulatory compliance across all CMC deliverables.

CMC Regulatory Strategy: Lead CMC regulatory strategy for China Clinical Trial Applications (CTAs) and work closely with ExploR&D regulatory scientists and Chinese regulatory authorities to support successful submissions for both traditional IND studies as well as Investigator Initiated Trials (IIT’s). Ensure compliance with local requirements including import permits for investigational drugs, stability protocols, and manufacturing documentation.

Cross-Functional Collaboration: Serve as the CMC representative on cross-functional project teams, partnering with Regulatory Affairs, Clinical Operations, Quality, and Supply Chain to advance programs through development milestones.

External Partner Management: Build a China-based CDMO network and oversee the CDMO relationships. Lead technical assessments of potential partners and ensure technology transfer activities meet timelines and quality expectations.  Partner with ExploR&D global CMC team in the identification and evaluation of CDMOs to pilot new capabilities in AI/ML-based autonomous or semi-autonomous lab operations.

Risk Management: Proactively identify CMC-related risks to program costs, timelines or quality and develop mitigation strategies. Communicate effectively with leadership on program status, issues, and resource needs.

• Education: PhD in chemistry, chemical engineering, biochemistry, pharmaceutical sciences or a related discipline along with 8+ years of CMC development experience in the pharmaceutical or biopharmaceutical industry.
• Knowledge of China regulatory requirements, including CTA submissions and NMPA interactions. The candidate must possess strong knowledge of ICH guidelines and their application within China's regulatory framework.
• Fluency in Mandarin Chinese (spoken and written) is required, along with professional proficiency in English to facilitate communication with global teams.

• Experience with advanced modalities such as antibody-drug conjugates (ADCs), peptides, oligonucleotides, mRNA-based therapeutics or cell and gene therapy is highly desirable
• Experience with laboratory automation, in silico models or AI/ML tools applied to CMC development activities.
• Experience working with biotechs/emerging companies and/or early-stage development programs where speed to clinic is a critical success factor
• Demonstrated ability to operate effectively in fast-paced environments where rapid decision-making and pragmatic problem-solving are essential to maintain program momentum
• Track record of supporting multiple concurrent programs with varying levels of technical maturity, demonstrating agility in shifting priorities and creative approaches to address emerging challenges

• Travel up to 20% 

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 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.