Associate Director - Parenteral Operations Expansion at Eli Lilly and Company

Pleasant Prairie, Wisconsin, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Bachelor's degree in a science, engineering, or pharmaceutical related field of study
5+ years experience working in the pharmaceutical industry

Responsibilities

Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the Parenteral manufacturing area
Responsible for a workforce of approximately 25-50 individuals on various shifts, with multiple shift supervisors reporting directly
Ensure consistency of operations across shifts through active engagement on the shop floor, Gemba walks, and Practice vs. Procedure evaluations
Provide leadership and develop objectives to deliver Business Plan Goals related to production volumes, financial, safety, quality, stewardship, and people
Maintain metrics to measure performance against business objectives and make needed changes to improve performance
Participate in the development and implementation of strategies associated with Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), and Operational Standards for Supply Chain Excellence (OSSCE)
Lead/conduct area deviation and corrective action discussions with cross-functional teams from Engineering, Maintenance, Technical Services/Manufacturing Sciences (TS/MS), Quality, and Health, Safety, and Environmental (HSE)
Function as a primary contact for areas such as Production Planning, HR, Quality Assurance, Engineering, and Environmental/Safety issues
Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for audit tours and discussions
Lead the Operations Process Team, a cross-functional group charged with making medicine, continuous improvement, and site support
Understand and influence the manufacturing control strategy for the area
Lead by example and provide coaching in safety, quality, operational execution, sterility assurance, and continuous improvement
Lead the operations group supporting asset delivery, process development, operational readiness, startup, and validation of the Kenosha parenteral expansion
After startup, lead all aspects of day-to-day activities and plan for the 3-6 month horizon
Lead the respective process team per Lilly’s Manufacturing Standards for Operational Excellence

Skills

Leadership

Staffing

Training

Process Development

Operational Readiness

Startup

Validation

Safety

Quality

Sterility Assurance

Continuous Improvement

Operational Excellence

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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