Analytical Steward: Data Integrity & Method Validation

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

Company bonus

401(k) and pension

Vacation benefits

Medical/Dental/Vision benefits

Flexible benefits

Life insurance

Job summary

Lilly is seeking a highly skilled Scientist in Indianapolis to lead data review, method validation, and tech transfer activities. You will drive investigations, ensure regulatory‑compliant validation packages, and support cross‑site testing for batch release and stability.

The role emphasizes ALCOA++ data integrity, audits, and collaboration across GMP labs, with a path toward advanced analytical method improvements and regulatory submissions.

Qualifications

• Bachelor degree in a science field related to the lab (Chemistry, Biochemistry, Pharmacy).
• 5+ years of industry related experience in pharmaceuticals in a GMP lab.
• Authorized to work in the United States on a full-time basis; visa support not provided.

Responsibilities

• Technical review, interpretation, and release of data from CM, stability, process validation, and reference standard characterization.
• Lead or perform investigations for out-of-spec results and root cause analysis with corrective actions.
• Develop investigational testing protocols and oversee testing as required.
• Contribute to APR, tech transfer, and process validation activities.
• Communicate effectively within API EM and with external partners; participate in audits as needed.
• Coordinate testing across sites for batch release, stability, or validation testing.
• Perform method assessments and ensure validation packages meet regulatory expectations.

Skills

Data integrity

Root Cause Analysis

Analytical problem solving

Cross-functional teamwork

Effective communication

Laboratory analysis

Method validation transfer

Education

Bachelor degree in a science field (Chemistry, Biochemistry, Pharmacy)

Tools

HPLC

GC

KF

Particle size analysis

CSV / Computer systems validation

Job description

Lilly is seeking a highly skilled Scientist in Indianapolis to lead data review, method validation, and tech transfer activities. You will drive investigations, ensure regulatory‑compliant validation packages, and support cross‑site testing for batch release and stability.

The role emphasizes ALCOA++ data integrity, audits, and collaboration across GMP labs, with a path toward advanced analytical method improvements and regulatory submissions.