Assoc. Dir – Lab Methods & Instrument Management (LabVantage, QC Labs) at Eli Lilly and Company

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, BiotechnologyIndustries

Requirements

Expertise in LabVantage LIMS (Laboratory Information Management System) technology
Knowledge of regulatory requirements including GMP, GxP, 21 CFR Part 11, and Annex 11
Experience with data integrity principles (ALCOA+), audit trails, and secure access controls
Ability to lead design, configuration, governance, change control, validation, and release management of LIMS modules
Skills in master data management, instrument management, and connectivity
Capability to manage teams for instrument drivers and metadata
Experience partnering with global stakeholders, Analytical Development, QA, Engineering, and IT

Responsibilities

Lead the design, configuration, and governance of LabVantage modules supporting QC testing, Lab Methods, and Instrument Management
Ensure the LIMS supports regulatory and data integrity requirements (GMP, GxP, 21 CFR Part 11, Annex 11)
Oversee change control, validation, and release management of new functionalities and configurations
Govern the creation, approval, and lifecycle maintenance of analytical test methods within LabVantage
Ensure method parameters, specifications, and versioning are accurately configured and linked to products and stability protocols
Partner with global stakeholders, Analytical Development, and QA to digitally standardize and harmonize test methods across manufacturing sites
Drive method verification, migration, and archival processes during method transfers or updates
Manage a team that creates drivers for instruments supporting lab methods and ensures connectivity to LabVantage
Ensure all instrument metadata and status are accurately reflected for real-time availability and compliance
Collaborate with Engineering and IT to ensure instrument connectivity, validation, and audit-readiness
Implement and enforce data governance frameworks within LabVantage for QC operations
Ensure compliance with data integrity principles (ALCOA+), audit trails, and secure access controls
Support internal and regulatory audits by ensuring traceable and compliant method and instrument records

Skills

Key technologies and capabilities for this role

LabVantageLab MethodsInstrument ManagementQC LabsLaboratory Management

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require working on-site?

This information is not specified in the job description.

What are the key responsibilities for this role?

The role involves leading LabVantage LIMS technology initiatives for QC operations, including design, configuration, governance of modules for QC testing, Lab Methods, and Instrument Management, ensuring regulatory compliance, and overseeing laboratory methods lifecycle management.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people, puts people first, hires diverse technology professionals for innovative solutions, and emphasizes giving best effort to work while advancing medicines through technology.

What makes a strong candidate for this Associate Director role?

Strong candidates will have leadership experience in LabVantage LIMS for pharmaceutical QC labs, expertise in master data and instrument management, and knowledge of regulatory requirements like GMP, GxP, 21 CFR Part 11, and Annex 11.

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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