Analytical Technical Steward

Eli Lilly • Indianapolis, IN

423d • $63,000 - $140,800

About The Position

The Analytical Technical Steward at Lilly plays a crucial role in ensuring that analytical testing of products at multiple sites meets both internal and external quality standards. This position involves reviewing data from contract manufacturers, leading investigations into laboratory-related issues, and collaborating with cross-functional teams to establish robust analytical control strategies. The steward is responsible for maintaining compliance with regulatory expectations and driving continuous improvement in laboratory processes.

Requirements

• Bachelor degree in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmacy or equivalent experience).
• Minimum of 3 years of industry related experience in pharmaceuticals in a GMP lab.

Nice To Haves

• Demonstrated proficiency in complex laboratory analysis including chromatographic (both HPLC and GC), spectroscopic, and LC-MS.
• Deep understanding of compliance requirements and regulatory expectations.
• Demonstrated accuracy and proficiency in analytical skills.
• Demonstrated strong problem-solving skills.
• Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology.
• Strong oral and written communication skills demonstrated through documentation and presentations.
• Demonstrated strong interpersonal interaction skills.
• Ability to work in cross functional teams as well as across networks.
• Demonstrated analytical skills.
• Demonstrated experience with method qualification, validation, and transfer.

Responsibilities

• Technical review, interpretation, and release of data including data released from CM, stability, process validation, and reference standard characterization.
• Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data.
• Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence.
• Develop investigational testing protocols and perform testing as required.
• Contribute to APR, tech transfer, and process validation as required.
• Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners.
• Participate in internal/external audits as needed.
• Develop and ensure execution of quality plan projects.
• Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing.
• Performs method assessments, with deficiencies and areas for improvement noted within the assessments.
• Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs.
• Participates in method validations according to Global Quality Standards.
• Review of analytical test method packages.
• Approval of test method protocols.
• Approval of new test methods or changes or deletions to existing test methods.
• Provides laboratory support for marketed products including laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions.
• Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies.
• Improve assays in QC, including variability reduction, method optimization, and new method development.
• Local and Global Method Change Control Ownership.
• Oversight of reference standard evaluations per Global Quality Standards.
• Selection of appropriate packaging materials.
• Consult in the preparation of the characterization protocol for corporate reference standards.
• Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards.
• Participate in the review of the reference standard profile and associated documentation for data integrity.
• Method transfers to Contract Manufacturers.
• Oversee transfer of analytical methods for marketed products to CM laboratories or to designated third party QC labs.
• Monograph review and implementation.
• Ensures consistent practices between laboratories running the same methods.
• Effective management of multiple projects.

Benefits

• Health insurance
• Dental insurance
• 401(k)
• Flexible spending account
• Employee assistance program
• Vision insurance
• Life insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree