Lead CMC Analytical Chemist, Antibody-Drug Conjugates

BioSpace; Indianapolis (IN); On-site; USD 126,000 - 205,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision

Flexible benefits

Life insurance

Well-being benefits

Job summary

Lilly is seeking an experienced CMC Analytical Chemistry Advisor to advance ADC development at the Indianapolis site. You will lead analytical development for ADC drug substances and products, collaborate across chemistry, formulation, and engineering teams, and contribute to regulatory submissions.

The role emphasizes leadership in analytical strategy, transfer to manufacturing or CROs/CMOs, and staying abreast of evolving industry guidelines in a fast-paced setting.

Qualifications

• Ph.D. in Analytical Chemistry or related STEM with 3+ years in pharma, or MS with 8+ years, or BS with 10+ years.
• Proven leadership in CMC analytical development for therapeutic biologics.
• Strong expertise in HPLC, LC/MS, CE, impurity profiling, and method validation.
• Familiar with ICH guidelines and regulatory requirements.

Responsibilities

• Develop and validate analytical methods for ADC conjugated drug substance/drug product.
• Lead lab activities on purity/impurity method development and analytical testing.
• Deliver robust control strategies for ADC drug substances, drug products, and mAb intermediates.
• Provide technical oversight for analytical development and tech transfer to CROs/CMOs.
• Support regulatory submissions (IND, BLA) and responses to RtQs.
• Mentor scientific staff and manage development timelines and resources.
• Collaborate with cross-functional teams including process chemists and formulation scientists.

Skills

HPLC

LC/MS

CE

Impurity profiling

Method validation

Analytical problem-solving

Leadership

Education

PhD in Analytical Chemistry

MS in Analytical Chemistry

BS in Analytical Chemistry

Job description

Lilly is seeking an experienced CMC Analytical Chemistry Advisor to advance ADC development at the Indianapolis site. You will lead analytical development for ADC drug substances and products, collaborate across chemistry, formulation, and engineering teams, and contribute to regulatory submissions.

The role emphasizes leadership in analytical strategy, transfer to manufacturing or CROs/CMOs, and staying abreast of evolving industry guidelines in a fast-paced setting.