Senior / Principal Process Engineer - APIEM at Eli Lilly and Company

Kinsale, County Cork, Ireland

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

PharmaceuticalIndustries

Requirements

Expertise in Synthetic Peptide Synthesis and Purification / Small Molecule processes
Technical leadership and expertise in process engineering for API manufacturing at Contract Manufacturers (CMs)
Past experience with unit operation control strategies
Proficiency in statistical thinking, data analysis, and process modeling (e.g., material/energy balances, kinetics, equipment design)
Knowledge of FUME assessments, HSE, PSM elements, and risk management
Experience with equipment specification, procurement, IQ/OQ/PQ, and optimization tools
Familiarity with Lilly Red Book expectations for CM interactions

Responsibilities

Provide technical leadership and expertise to ensure reliable supply and commercialization of medicines with safety first and quality always
Develop and sustain process knowledge to execute appropriate product, process, and operational control strategies at CMs
Interact directly and indirectly with CM personnel to ensure execution of operational control strategies
Conduct FUME assessments to understand risks to operational control strategies
Participate in equipment specification, procurement, and IQ/OQ/PQ with internal or CM resources
Assess HSE and PSM elements at CMs impacting Lilly products
Engage with internal and external resources to develop capabilities with new or evolving technologies
Adhere to Lilly Red Book expectations in interactions with API EM CMs
Coach and mentor Process Team Members, providing insight from past experiences and championing statistical thinking
Support and peer review root cause analysis for FUME and operational incidents, and review documentation of learning points, studies, and investigations
Identify process knowledge gaps and support capture of key process knowledge (e.g., balances, kinetics, models)
Enable maintenance of process knowledge infrastructure (e.g., models, report history, lab models, literature)
Utilize optimization resources for process analysis, improvement studies, and tracking key engineering metrics
Identify systemic issues affecting production and reliable supply from CMs
Lead or participate in root cause analysis and countermeasure implementation for safety, quality, or throughput incidents
Review and approve incident documentation, engineering decisions, and technical accuracy
Support development and technical analysis for continuous improvement activities
Review cost reduction opportunities, process capacities, and bottlenecks, assisting in prioritization aligned with business objectives
Work with CMs to apply statistical methods for understanding process variability and capability
Promote optimization of unit operation cycle time, loading, and yield performance
Engage with late phase development resources

Skills

Synthetic Peptide Synthesis

Purification

Small Molecule Processing

Process Control Strategy

FUME Assessment

Equipment Specification

IQ/OQ/PQ

HSE

PSM

Risk Assessment

Process Engineering

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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