Associate Director - Drug Product External Manufacturing - Technical Services at Eli Lilly and Company

Indianapolis, Indiana, 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

Leadership experience in technical services for external manufacturing in pharmaceuticals
Expertise in cGMP compliance, regulatory commitments, and Lilly Functional Standards
Knowledge of validated processes, control strategies, and manufacturing/packaging/distribution operations
Ability to ensure inspection readiness and quality oversight for external partners
Skills in validation strategies, protocol approvals, change control, deviations, root cause analysis, CAPAs, APRs, ARs, and OPVs
Experience in building relationships with contract manufacturers (CMs) and external benchmarking
Capability to assess CM capabilities for selection and provide functional recommendations
Membership or ability to participate in governance teams (e.g., Flow Team, Science Lead Team, Site Quality LT)

Responsibilities

Lead the technical service primary loop team providing oversight for external manufacturing per Global Contract Manufacturing Standards
Ensure technical excellence, compliance, and deliverables for day-to-day operations in making and supplying medicines and new product commercialization
Provide oversight for reliable supply through effective manufacturing processes at CMs
Establish and maintain robust control strategies aligned with Lilly standards and regulatory submissions
Ensure departments and external partners comply with cGMPs, regulatory commitments, and Lilly standards; maintain inspection readiness
Ensure quality of externally manufactured products via oversight, CAPAs, metrics, and monitoring
Build relationships with CMs for alignment of intents and objectives
Oversee validation strategies, revisions, protocols, plans, reports, and master plans; approve documents
Evaluate and assess changes to validated processes, regulations, and commitments
Evaluate deviations' impact on products, processes, and control strategies; ensure root cause identification, CAPAs, and timely investigations
Ensure timely completion of APRs, ARs, OPVs, and process reviews in compliance with standards
Maintain compliant external manufacturing documentation (e.g., Quality Agreements, Manufacturing Requirements Documents)
Create external benchmarking opportunities and identify best practices
Oversee execution of technical agendas at external partners aligned with business plans, cGMPs, and standards
Escalate risks to supply, manufacturing issues, major deviations, safety, or cybersecurity to Sr. Management
Lead implementation of process improvements, control strategy updates, or new regulations into CM technical agendas
Contribute to CM selection by assessing capabilities and recommending sourcing options
Serve as member of Flow Team, Science Lead Team (LT), and Site Quality LT; support functional business plans

Skills

cGMP

Technical Oversight

Contract Manufacturing

Process Validation

Control Strategy

CAPA

Regulatory Compliance

Inspection Readiness

Manufacturing Process

Supply Chain Oversight

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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