Sr. Director - API Operations at Eli Lilly and Company

Richmond, Virginia, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

Bachelor’s degree in a relevant discipline
10+ years of experience leading operations within the pharmaceutical industry

Responsibilities

Lead collaboratively and energetically across all aspects of operational readiness and startup (Pre-Startup and Startup Phase)
Build an organization with the capability, capacity, and culture to achieve high standards in safety, quality, and operational excellence (Pre-Startup and Startup Phase)
Develop and implement site systems and processes, drawing on internal expertise and external best practices (Pre-Startup and Startup Phase)
Embed lean principles and a continuous improvement mindset across operations and support functions (Pre-Startup and Startup Phase)
Act as the end-user representative during project delivery—providing input on design, commissioning, and startup decisions to ensure alignment with project goals and long-term strategy (Pre-Startup and Startup Phase)
Develop and execute strategic and operational plans for Production Operations (Post Startup)
Contribute to the site’s medium- and long-term strategic direction (Post Startup)
Ensure compliance with all applicable regulatory requirements (e.g., safety, quality/cGMP, environmental, financial, legal, HR) (Post Startup)
Ensure Production Flow and Process Teams meet Lilly’s Manufacturing Standards for Operational Excellence (Post Startup)
Maintain robust control systems to manage operations, identify compliance risks, and escalate issues appropriately (Post Startup)
Monitor site and business area performance and take corrective action as needed (Post Startup)
Lead cross-functional teams to implement new product introductions and continuous improvement initiatives (Post Startup)
Develop future management and technical leaders for site and global roles (Post Startup)

Skills

Key technologies and capabilities for this role

GMPManufacturing OperationsMonoclonal AntibodiesBioconjugatesAseptic ProcessingLeadershipOrganizational DevelopmentSafety CultureFacility StartupStrategic Planning

Questions & Answers

Common questions about this position

What is the employment type for this Sr. Director role?

The position is full-time employment.

Is this role remote or based at a specific location?

The role is based at Lilly's new advanced manufacturing facility in Goochland County, Virginia.

What leadership and operational skills are required for this position?

The role requires strong leadership to build manufacturing organizations, develop GMP systems and processes, embed lean principles and continuous improvement, and ensure compliance with safety, quality/cGMP, and regulatory requirements.

What is the company culture like for this role at Lilly?

The culture emphasizes putting people first, safety, quality, operational excellence, lean principles, continuous improvement, and alignment with long-term business goals as part of the site leadership team.

What makes a strong candidate for the Sr. Director - API Operations role?

Strong candidates have experience leading manufacturing startups, building organizations and leadership structures, integrating cross-functional teams, and contributing to strategic direction in GMP environments.

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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