Associate Director - Biotech Operations at Eli Lilly and Company

Limerick, County Limerick, Ireland

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Leadership experience in biotech or pharmaceutical manufacturing operations
Ability to provide technical leadership and direction to cross-functional process and manufacturing teams
Expertise in GMP manufacturing, safety, quality, and environmental standards
Experience with new product introductions, site inspections, change management, and continuous improvement
Strong people management skills, including building teams, training, performance management, and development
Proven ability to manage collaborations with functional support groups (e.g., maintenance, engineering, analytical)
Collaborative, inclusive, and energetic leadership style suitable for greenfield site startup
Experience in site management and participation in cross-functional management teams

Responsibilities

Promote a strong Safety and Quality culture
Participate in the creation, approval, and execution of the production plan for the assigned area
Maintain a safe working environment and conduct production activities protecting safety, environment, and quality
Ensure consistency of operations across shifts through active engagement on the production floor
Ensure all necessary systems, procedures, equipment, and facilities are installed, qualified, validated, and maintained to standards
Support New Product Introductions to the site as required
Support and provide leadership during site inspections
Own the implementation of the change and improvement agenda for the assigned area
Set objectives for the cross-functional Process Team and own/review their scorecard with management
Manage events, ensure appropriate communication, provide input, and approve investigations
Build a team, creating clear common purpose and promoting good team spirit
Ensure team members are appropriately trained with current operating procedures and training materials
Manage people training, qualification, performance; set job expectations and goals linked to team/site goals; develop people
Communicate site objectives and team business appropriately with team members
Ensure the team is adequately resourced to meet business objectives
Manage collaborations between the team and functional support groups (e.g., maintenance, engineering, analytical, financial, purchasing, technical support)
Serve as an engaged member of the cross-functional management team (Flow team) and Site Management
During startup phase: Support building the organization, facility, and culture for successful GMP operations

Skills

Key technologies and capabilities for this role

Biotech OperationsGMP ManufacturingSafety ManagementProcess LeadershipCross-Functional TeamsManufacturing StartupData Analysis PlatformsBioprocessing

Questions & Answers

Common questions about this position

What is the location of this position?

The position is based at Lilly’s Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland.

What does the role report to?

The Associate Director-Biotech Operations reports to the Senior Director-Biotech Operations.

What are the key responsibilities of this role?

Key responsibilities include promoting a strong Safety and Quality culture, participating in production planning, maintaining a safe working environment, ensuring consistency across shifts, supporting new product introductions, and leading the cross-functional Process Team.

What is the company culture like at Lilly?

Lilly emphasizes putting people first, uniting caring with discovery, a strong Safety and Quality culture, and building the organization, facility, and culture for successful startup GMP manufacturing operations.

What experience is needed to succeed in this role?

Leadership experience in biotech operations is essential, particularly in providing direction to cross-functional process and manufacturing teams, managing daily operations, ensuring safety and quality, and building teams for a greenfield manufacturing site startup.

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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