Genetic Medicine Analytical Development Advisor

BioSpace; Indianapolis (IN); On-site; USD 126,000 - 244,000; Full time

Benefits offered by this job

401(k)

Medical benefits

Dental and vision

Vacation benefits

Job summary

Lilly, headquartered in Indianapolis, seeks an Advisor to advance analytical development for genetic medicines and ATMPs. This role focuses on developing and qualifying methods for drug substance/product quality attributes across portfolios, in a GMP/GLP environment.

The position requires expertise in molecular biology and nucleic acid analytics, with cross-functional collaboration to support IND/enabling studies through regulatory readiness.

Qualifications

• PhD/MS/BS with pharma/biotech experience as listed in the ad.
• Experience with qPCR/ddPCR in a pharmaceutical context.
• Experience with immunoassays for impurities or QA testing.
• Ability to design experiments and interpret data independently.

Responsibilities

• Develop, qualify, and execute PCR-based methods for genome titration and DNA quantitation.
• Apply immunoassays for residual host cell protein testing and impurity analysis.
• Contribute to analytical control strategies and CQAs for DS/DP.
• Support qualification, verification, and validation per ICH Q2(R2).
• Collaborate across cross-functional teams to support clinical trials and regulatory submissions.

Skills

qPCR/ddPCR proficiency

Immunoassay platforms

Molecular biology techniques

Data interpretation

GMP/GLP familiarity

Education

PhD in Molecular Biology/Biochemistry/Biology/Analytical Chemistry

MS in Molecular Biology/Biochemistry/Biology/Analytical Chemistry

BS in Molecular Biology/Biochemistry/Biology/Analytical Chemistry

Tools

Benchling

ELN

Job description

Lilly, headquartered in Indianapolis, seeks an Advisor to advance analytical development for genetic medicines and ATMPs. This role focuses on developing and qualifying methods for drug substance/product quality attributes across portfolios, in a GMP/GLP environment.

The position requires expertise in molecular biology and nucleic acid analytics, with cross-functional collaboration to support IND/enabling studies through regulatory readiness.