Associate Director - TS/MS Device & Packaging at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, HealthcareIndustries

Requirements

Leadership experience in leading, mentoring, coaching, and developing technical staff
Expertise in providing technical and process support for production issue resolution, investigations, and regulatory compliance
Ability to foster innovation, creativity, and continuous improvement in device assembly and packaging processes
Experience in technology transfers, control strategy development, process validations, and equipment/line implementation
Skills in collaborative leadership, representing teams on cross-functional plant flow teams, and working with internal/external partners and suppliers
Proficiency in resource management, including workload optimization, staffing, and building diverse teams
Capability in strategic planning, tracking performance, and supporting business plan objectives
Knowledge of safety, quality culture, and GMP documentation review/approval (procedures, deviations, technical reports, change controls, regulatory submissions, validation protocols/reports, PFDs, APRs)
Experience in developing and communicating performance metrics for safety, quality, process effectiveness/efficiency
Understanding of regulatory compliance (cGMP, OSHA, environmental sustainability) and support for inspection readiness and agency interactions

Responsibilities

Lead, mentor, coach, and develop staff to foster continuous improvement in safety, quality, and technical capability
Provide technical and process support for production issues, investigations, reliable solutions, safe execution, and regulatory compliance
Foster knowledge sharing, education, and alignment with internal partners to meet manufacturing goals
Promote a culture of innovation, encouraging identification and implementation of improvement opportunities
Oversee technology transfers, control strategy development, process validations, and integration of business/quality systems for commercial launch
Represent the team on plant flow teams, influence technical agendas, and drive operational results through cross-functional collaboration
Manage resources, optimize workloads, and support staffing for device assembly and packaging areas
Engage in strategic planning, track team performance, and ensure resources for business plan implementation
Lead by example in building a safety-first and quality-always culture, removing barriers to performance
Review and approve GMP documentation, including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols/reports, PFDs, and APRs
Develop and communicate department metrics and team goals for safety, quality, effectiveness, and efficiency
Ensure adherence to regulatory requirements (cGMP, OSHA, sustainability), support inspection readiness, and interact with regulatory agencies

Skills

Manufacturing Science

Technical Services

Device Assembly

Packaging Processes

Process Support

Issue Resolution

Investigations

Regulatory Compliance

Operational Excellence

Continuous Improvement

Leadership

Mentoring

Innovation

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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