Analytical Technical Steward: API QC & Method Expert

Eli Lilly and Company; Indianapolis (IN); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

Bonus potential

Company 401(k)

Pension

Vacation benefits

Medical/Dental/Vision benefits

Job summary

Lilly, headquartered in Indianapolis, Indiana, seeks an Analytical Technical Steward for API External Manufacturing QC. The role ensures analytical testing aligns with Lilly and external requirements across multiple sites, focusing on small molecules.

You will lead investigations, develop testing protocols, and collaborate with development and global lab teams to ensure robust control strategies. Key responsibilities include method validation, transfer, and continuous improvements;

Qualifications

• Bachelor degree (4 year College) in a science field related to the lab (e.g. 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. Lilly will not sponsor work authorization or visas.

Responsibilities

• Technical review, interpretation, and release of data including data released from CM, stability, process validation, and reference standard characterization.
• Lead investigations for out of specification results and aberrant data; perform root cause analysis and recommend solutions.
• Develop investigational testing protocols and perform or oversee testing as required.
• Support APR, tech transfer, and process validation; participate in audits as needed.

Skills

Problem solving

Communication skills

Interpersonal skills

Cross-functional teamwork

Education

Bachelor degree in science

Tools

HPLC

GC

KF

Job description

Lilly, headquartered in Indianapolis, Indiana, seeks an Analytical Technical Steward for API External Manufacturing QC. The role ensures analytical testing aligns with Lilly and external requirements across multiple sites, focusing on small molecules.

You will lead investigations, develop testing protocols, and collaborate with development and global lab teams to ensure robust control strategies. Key responsibilities include method validation, transfer, and continuous improvements;