Sr. Director - Technical Services/Manufacturing Sciences at Eli Lilly and Company

Durham, North Carolina, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, BiotechnologyIndustries

Requirements

Active member of the RTP Site Lead Team ensuring safety, quality, and operational excellence
Provide Health, Safety and Environmental (HSE) and Quality leadership for areas of responsibility, ensuring cGMP requirements are met, with direct interaction with Regulatory Agencies during site inspections
Support Site Leadership to build a diverse and capable site organization, including talent management, development, and retention
Provide site functional leadership and develop objectives to deliver Business and Strategic Plan Goals related to safety, quality, technical effectiveness, and efficiency
Understand scientific principles for manufacturing parenteral drug products, including interactions of chemistry, equipment, aseptic processes, and container closure systems
Lead risk management activities pertaining to products

Responsibilities

Oversee manufacturing process control and validation strategy for RTP products in device assembly, packaging, and syringe filling operations
Support delivery of equipment and supporting systems through user requirements, design, build, commissioning, qualification, validation, and operation
Support and/or lead TS/MS technical projects to improve process control, yield, product quality, and/or productivity; implement process changes and improvements through the tech agenda
Develop, monitor, and react to statistically based metrics in real-time to assess process variability and capability
Develop local processes and procedures for the TS/MS function
Ensure accurate instruction set (tickets & procedures) describes the process and control strategy for discrete manufacturing steps
Ownership of the Site Validation Plan and lead site validation efforts
Ownership of the Site Sterility Assurance Plan
Drive stability strategy for RTP products
Ensure alignment to meet production throughput goals, including daily operations, deviation and change management, variability reduction, and equipment/system reliability
Develop and maintain metrics to measure performance against business objectives and make necessary changes to improve performance
Active leadership in the implementation of Lean principles

Skills

cGMP

Technical Services

Manufacturing Sciences

Parenteral Manufacturing

Device Assembly

Packaging Operations

HSE

Quality Leadership

Regulatory Inspections

Site Leadership

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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