TSMS-API Manufacturing Support Scientist at Eli Lilly and Company

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Strong understanding of pharmaceutical manufacturing principles and Lilly systems
Knowledge of cGMPs, applicable global regulatory manufacturing guidance, and corporate/industry standards
Ability to work cross-functionally within the site and other functions to deliver on technical objectives
Understanding of the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment

Responsibilities

Provide technical oversight and stewardship for manufacturing processes
Ensure that processes are compliant with US and global regulations, capable, in control, and maintained in a validated or qualified state
Prepare and support technical transfer documents and activities
Lead resolution of technical issues, including those related to control strategy and manufacturing
Execute technical projects to improve process control, yield, purity, and/or productivity
Ensure proper characterization of processes and products, and effective documentation of process description, measures, acceptable ranges, and specifications (including justification)
Understand, justify, and document the state of validation with data evaluating the capability of the manufacturing process
Prepare relevant technical documents, such as technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, etc
Develop and monitor established metrics in real-time to assess process variability and capability
Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for discrete manufacturing steps
Analyze data and ensure appropriate documentation
Write technical reports and documents
Provide day-to-day production support
Serve as a member of IPT/JPT and act as a liaison between the IPT and contract manufacturing (CM) process team
Oversee CM facility operations and provide technical support for assigned API intermediate and API manufacturing processes

Skills

cGMP

API Manufacturing

Pharmaceutical Manufacturing

Regulatory Compliance

Contract Manufacturing

Technical Services

Manufacturing Science

Quality Standards

Cross-Functional Collaboration

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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