APIEM Associate Director – Joint Process Team at Eli Lilly and Company

Hyderabad, Telangana, India

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Experience in pharmaceutical manufacturing preferred
Strong understanding of quality systems and regulatory requirements
Excellent communication and interpersonal skills
Ability to lead and motivate cross-functional teams
Experience with technology transfer and process validation

Responsibilities

Lead cross-functional Joint Process Team (JPT), between Lilly and contract manufacturer (CM), to develop and implement strategically aligned Quality and Supply Plans as well as the Technical Agenda for the CM
Successfully facilitate and champion quality, technical, and regulatory compliance to ensure continuous supply to the marketplace
Manage technology transfer, production, batch release and shipment schedules to ensure appropriate resources to meet objectives
Resolve supply chain issues and provide internal notification to management or joint Lilly/CM Steering Team as necessary
Accountable for the metrics that align with Manufacturing Standards of Excellence for External Manufacturing and API EM procedures to monitor performance at the CMs, and to review these at API external manufacturing Flow Team and Site Lead Team meetings
Serve as liaison to communicate status and issues to various management levels in operations, quality, manufacturing and business unit networks
Ensure Lilly and CM is roles and responsibilities associated with the contract (Master Supply Agreements, Work Orders, etc) and Quality Ag

Skills

Pharmaceutical Manufacturing

Quality Systems

Regulatory Requirements

Technology Transfer

Process Validation

Cross-Functional Leadership

Communication Skills

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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