Analytical Technical Steward-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

PharmaceuticalIndustries

Requirements

Technical expertise in analytical methods and peptide characterization
Experience reviewing and interpreting analytical data from contract manufacturers
Ability to lead or perform in-depth investigations of out-of-specification results and aberrant data
Strong problem-solving and root cause analysis skills
Excellent communication skills (written and oral)
Ability to travel to the contract manufacturer site (up to four times per week)
Understanding of API EM Risk Based Oversight Governance

Responsibilities

Review, interpret, and release data including data released from Contract Manufacturers (CM), stability data, process validation data, and reference standard characterization
Utilize technical skills to lead or perform in-depth investigations for out-of-specification results and aberrant data, drawing conclusions and performing root cause analysis investigations and recommending solutions to prevent reoccurrence
Develop investigational testing protocols and perform testing as required
Contribute to APR (Annual Product Review), tech transfer, and process validation as required
Communicate effectively in both written and oral formats within the API EM organization and with external customers and business partners
Participate in internal/external audits as needed
Develop robust analytical control strategies and proactively identify opportunities for continuous improvement
Lead resolution of laboratory related manufacturing issues

Skills

Key technologies and capabilities for this role

Peptide CharacterizationAnalytical MethodsData ReviewOOS InvestigationsRoot Cause AnalysisStability DataProcess ValidationTech TransferAnnual Product ReviewAPI Oversight

Questions & Answers

Common questions about this position

What is the salary for the Analytical Technical Steward-Peptides role?

This information is not specified in the job description.

Is this position remote or onsite, and where is it located?

The position is onsite in Hyderabad, India, and requires frequent on-site visits to the contract manufacturer up to four times per week.

What skills are required for this Analytical Technical Steward-Peptides position?

Key requirements include technical expertise in analytical methods and peptide characterization, experience reviewing analytical data from contract manufacturers, ability to lead investigations of out-of-specification results, strong problem-solving and root cause analysis skills, and excellent communication skills.

What is the company culture like at Eli Lilly and Company?

Eli Lilly is committed to discovering life-changing medicines, improving disease management, and giving back to communities through philanthropy and volunteerism, striving to unite caring with discovery to make life better worldwide.

What makes a strong candidate for this role?

A strong candidate will have technical expertise in analytical methods and peptide characterization, proven experience with data review from contract manufacturers, strong investigative and problem-solving skills, excellent communication abilities, and willingness to travel frequently to sites.

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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