Analytical Technical Steward Peptides and Oligonucleotides at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Technical expertise in analytical testing for peptides and oligonucleotides
Ability to review and release data from contract manufacturers (CM), stability, process validation, and reference standard characterization according to API EM Risk Based Oversight Governance
Proficiency in in-depth problem solving, root cause analysis, and investigations of out-of-specification results and aberrant data
Capability to develop investigational testing protocols and perform non-routine lab work
Strong communication skills in written and oral formats with internal teams, external customers, and business partners
Experience participating in internal/external audits
Knowledge of method assessments, validation packages, regulatory expectations, and compendial monographs
Ability to approve test method protocols, new methods, changes, or deletions
Skills in laboratory support including method development, validation, implementation, and training/transfer for marketed products

Responsibilities

Technical review, interpretation, and release of data including data released from CM, stability, process validation, and reference standard characterization
Utilize technical skills to lead or perform in-depth investigations for out of specification results and aberrant data; draw conclusions, perform root cause analysis, and recommend solutions to prevent reoccurrence
Develop investigational testing protocols and perform testing as required
Contribute to APR, tech transfer, and process validation as required
Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners
Participate in internal/external audits as needed
Develop and ensure execution of quality plan projects
Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing
Perform method assessments, noting deficiencies and areas for improvement
Ensure method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs, including evaluating existing data and updating packages as needed
Participate in method validations according to Global Quality Standards
Review analytical test method packages
Approve test method protocols
Approve new test methods or changes or deletions to existing test methods
Provide laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including laboratory work, training/transfer)

Skills

Analytical Testing

Quality Control

Data Review

Deviation Management

Stability Data

Problem Solving

Root Cause Analysis

Laboratory Techniques

Continuous Improvement

Risk Based Oversight

Data Integrity

Peptides

Oligonucleotides

API Manufacturing

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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