API EM TS/MS Mfg. Scientist – Peptides 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

PharmaceuticalsIndustries

Requirements

Strong understanding of manufacturing principles
Knowledge of cGMPs
Familiarity with applicable global regulatory manufacturing guidance
Understanding of corporate/industry standards
Ability to work cross-functionally

Responsibilities

Develop and sustain process knowledge to ensure the execution of the appropriate product, process, and operational control strategy at the Contract Manufacturer (CM)
Direct and Indirect interaction with CM personnel to ensure reliable supply via the CM execution of the operational control strategy
Participate with internal or CM resources in technical transfer, process validation, and process data monitoring
Adherence to the expectations of the Lilly Red Book when carrying out interactions with API EM’s CMs
Process monitoring and response to issues, including improvements where necessary
Lead resolution of technical issues related to control strategy and manufacturing
Ensure processes are compliant, capable, in control, and maintained in a validated or qualified state
Enable the development and maintenance of process knowledge infrastructure
Review and track key process parameters (i.e. CPP’s, rOPP’s, IPC, etc.)
Build and Sustain Process Team Relationships. Utilize past experiences with unit operation control to provide insight and feedback to members of the Lilly / CM Joint Process Team (JPT)
Employ excellent communication skills to manage internal and external relationships
Build and maintain relationships with development and central technical organizations
Operate with ‘Team Lilly’ in mind - including coaching and mentoring of peers and other scientists

Skills

cGMP

Process Validation

Technical Transfer

Process Monitoring

Regulatory Compliance

API Manufacturing

Peptides

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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