Associate Director - TS/MS - Lebanon API at Eli Lilly and Company

Lebanon, Indiana, United States

Apply Now

Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, ManufacturingIndustries

Requirements

Knowledge of cGMPs, applicable global regulatory manufacturing guidance, and corporate/industry standards for validation
Ability to balance coaching a technical staff, prioritization, and staffing for organizational build to support production activities
Capability to work cross-functionally within the site, network, commercialization teams, and other functions
Experience in leadership roles that are fluid and dynamic, with significant collaboration, creativity, and resilience during project delivery, startup, and scaling to full GMP manufacturing operations (particularly during 2025-2027 startup phase)

Responsibilities

Manage activities of TSMS personnel, including coaching, direction, formal performance management, and staff development
Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, and technical studies
Partner within TSMS and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives
Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits
Define strategic direction and provide oversight for setting the technical agenda to improve process control, yield, and/or productivity
Ensure adequate oversight and technical excellence for investigations and complaints
Ensure adequate oversight for technical projects to improve process control, capacity, yield, and quality
Ensure adequate technical representation and engagement within site and network governance meetings to influence technical agendas
Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites
Engage and influence Pharmaceutical Product Development groups for technical transfer deliverables for processes related to new molecule entities during commercialization stages

Skills

Key technologies and capabilities for this role

cGMPGMPValidationProcess OptimizationTechnical ServicesManufacturing ScienceRegulatory ComplianceAPI Manufacturing

Questions & Answers

Common questions about this position

What is the location of this position?

The position is located at Lilly's advanced manufacturing facility in Lebanon, IN.

What are the main responsibilities of the Associate Director TSMS role?

The role involves managing TSMS personnel, balancing coaching, prioritization and staffing, ensuring technical review and approval for documents like investigations and validations, completing performance management of staff, and partnering across functions to meet technical and quality objectives.

What skills or knowledge are required for this position?

The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and corporate/industry standards for validation, along with the ability to work cross-functionally and lead during a dynamic startup phase.

What is the company culture like at this new facility?

The role offers a unique opportunity to build the organization, facility, and culture for a successful startup into GMP manufacturing operations, requiring significant collaboration, creativity, and resilience as the site grows.

What makes a strong candidate for this Associate Director role?

Strong candidates will have experience managing technical staff in a GMP manufacturing environment, deep knowledge of regulatory standards and validation, and the leadership skills to coach teams, prioritize projects, and thrive in a fluid startup phase of a greenfield site.

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.

Land your dream remote job 3x faster with AI

Try Jobo Free