Associate Director-Quality Control at Eli Lilly and Company

Concord, North Carolina, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Bachelor of Science in Chemistry/Biology/Microbiology or related science
5+ years of GMP lab experience including analytical testing and method transfer
Previous pharmaceutical leadership experience including leading or working effectively with a cross-functional group
Deep understanding of compliance requirements and regulatory expectations
Excellent written and oral communication skills
Previous LEAN experience (preferred)
Experience operating or implementing Lab IT systems including LIMS and Automated Lab Execution systems (preferred)
Strong technical aptitude and ability to train and mentor others
Project management experience
Demonstrated problem-solving and decision-making capability
Demonstrated technical writing skills
Proven cross-functional collaboration skills

Responsibilities

Lead the Analytical Chemistry and Device testing teams
Serve as a technical resource to review and approve technical documents
Establish and maintain a QC Lab Operation compliant with Lilly Global Quality Standards and regulatory requirements
Develop and execute a lab operation strategy with a focus on chemical and device testing labs
Work with the Global Quality Lab Network and actively participate in global initiatives
Establish Lean Lab and efficient lab operations with a process for monitoring lab performance and continuously improving the operation
Ensure set up of all lab materials, chemicals, supplies, and services to support lab operation
Supervise, coach, and aid in employee development and performance management
Ensure all aspects of safety are incorporated into lab processes and maintain a safe work environment, supporting all HSE Corporate and Site Goals
Facilitate assessment of assay variability contribution to total process variability and ensure lab initiatives are aimed at reducing measurement variability. Interact with regulatory agencies during inspections regarding cGMP issues
Ensure data integrity by design
Work with Lab Robotics and Lab IT areas for integrating future technology and systems, including LIMS

Skills

GMP

Analytical Testing

Method Transfer

LIMS

LEAN

Lab IT Systems

Project Management

Regulatory Compliance

Technical Writing

Cross-functional Collaboration

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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