Eli Lilly and Company

Risk

• co-own the technical architecture and analytics engineering strategy for Lilly's enterprise risk management capabilities
• partner with risk owners across Ethics & Compliance, Legal, Privacy, Cybersecurity, Quality, HSE, Third Party Risk Management, and Corporate Audit Services to design and deliver analytics capabilities that transform how Lilly identifies and mitigates risk
• lead horizon scanning initiatives to identify emerging risks
• perform sophisticated risk event investigations that reveal systemic vulnerabilities
• develop ground-breaking strategies that fundamentally improve risk management across the organization
• design and build production analytics solutions using Microsoft Fabric ecosystem (Data Factory, Synapse Analytics, OneLake) with medallion architecture patterns, data governance frameworks, and CI/CD pipelines
• develop advanced Power BI semantic models with sophisticated DAX, performance optimization (query folding, aggregations, incremental refresh), and enterprise deployment patterns (shared datasets, deployment pipelines)
• architect scalable data infrastructure including lakehouse organization strategies, version control workflows, and automated testing frameworks
• provide hands-on development ownership for the most sophisticated risk analytics challenges
• establish and implement technical standards across DAX, Python, data modeling, and documentation
• lead architecture reviews and solution validation to ensure enterprise-grade quality, security, and performance
• evaluate emerging analytics technologies, AI/ML capabilities (including generative AI for risk intelligence), and industry practices
• architect integration patterns between risk management platforms (ServiceNow GRC), enterprise data systems, and analytics infrastructure
• co-own the enterprise risk analytics technology roadmap, coordinating priorities across risk functions and ensuring alignment with IRM strategic objectives
• lead technical discovery and requirements gathering for entrepreneurial analytics initiatives

Senior Director – Integrated Risk Analytics Architect

Full-stack Engineer

• As Principal Engineer, Technology Transfer and Process Engineering you will have an integral role in Technical Operations contributing to tech transfer and manufacturing of Verve’s novel gene editing products
• help facilitate drug product tech transfer efforts and drive successful clinical manufacturing by external vendors
• Drive technical readiness and on-site support for manufactures of LNP programs
• This includes batch record writing and executed record review, process scale-up, process data trending and support of quality activities including change controls, deviation investigations, implementation of process improvements
• Lead lessons learned and continuous improvement efforts at vendor sites
• Oversee the manufacturing campaigns (on-site) at the CMO, including troubleshooting in close cooperation with the CMO and internal stakeholders
• Lead transfer efforts of active clinical processes to secondary vendors to drive supply chain robustness
• Coordinate with Supply Chain on sourcing key components and raw materials to support a complex global drug product manufacturing network
• Collaborate with cross-functional teams including Process Development, Formulation, Preclinical Toxicology, Analytical Development, Quality Control, Quality Affairs, and External Manufacturing
• Write and provide technical review of GMP documents including tech transfer reports, best practices documents, SOPs, technical protocols, manufacturing batch records, campaign summary reports, etc.
• Write technical reports and contribute to global regulatory filings to support clinical development of Verve’s products

Senior Principal Engineer, Technology Transfer, Process Engineering, LNP

Analyst

• Align business objectives with digital and technical solutions for the Lilly Medicines Foundry
• Partner with business stakeholders and IT teams to define requirements, prototype, implement, and validate solutions
• Gather, analyze, and document business requirements to ensure alignment with stakeholder expectations
• Oversee the configuration, installation, and validation of digital systems for compliance
• Support application configuration, data accessibility, integration design, and BI reporting
• Facilitate cross-functional collaboration with business users and technical teams
• Enhance digital literacy on-site for ongoing support and innovation

Digital System Analyst

Compliance

• Provide Regulatory, Submission Planning and Execution Expertise
• Lead the registration management process by providing expertise in electronic submission regulations and guidance and technical content on a global and regional level
• Ensure compliance with all applicable regulations and internal quality systems
• Partner with other geographies and Regional Submission Associates for non-eCTD countries to provide submission content
• Support Affiliate Regulatory/Alliance Managers with RIM content planning for IND, MAA, Line extensions and new indication submission types
• Own the registration management process at the molecule/project level
• Serve as the RD&E operational lead for registration planning and execution
• Partner with the Global Regulatory Strategy Scientist/Regional/Affiliate Regulatory Staff to drive the execution of product deletion, divestiture process, IND inactivation/withdrawal process, product withdrawal process

Associate/Sr. Associate/Manager – Global Regulatory Affairs, Regulatory Delivery & Excellence

Attorney

• Lead the creation and implementation of legal and compliance training and communications
• Design and execute change strategies that enable successful adoption of new legal and compliance processes, technologies, and initiatives
• Plan, develop, and implement training solutions for prioritized legal, compliance, and integrated risk management topics
• Develop training and communication plans to support the implementation of identified legal, compliance, and integrated risk management initiatives
• Design and develop microlearning modules tailored to audience segments
• Identify simple and creative ways to communicate key messages
• Analyze available metrics and learner data to assess effectiveness to improve legal and compliance training and communications
• Develop and implement OCM strategies for legal and compliance initiatives
• Partner with leadership and cross-functional teams to align change efforts with business objectives
• Provide regular updates to leadership on progress, risks, and success measures
• Demonstrate a collaborative mindset and work effectively across teams
• Actively contribute to a culture of innovation and improvement

Associate Director – E&C and Legal Training

Operations

• Serve as the primary technical authority for RLT manufacturing and analytical topics
• Demonstrate calm, decisive leadership when challenges arise, using evidence‑based reasoning to drive resolution and maintain supply continuity
• Influence strategy and decision‑making by providing clear scientific rationale, shaping development approaches, and ensuring teams are aligned on technical priorities
• Lead all aspects of technology transfer for drug substance and drug product, ensuring analytical methods, process design, and validation strategies are scientifically robust and phase‑appropriate
• Drive seamless scale‑up and readiness for late‑stage clinical manufacturing
• Identify, establish, and maintain strong technical partnerships with CDMOs for manufacturing and analytical services
• Define and monitor metrics to ensure external manufacturing reliability and proactive risk mitigation for global RLT supply
• Partner closely with CMC development and translational radiochemistry teams to proactively identify and resolve scientific and operational challenges
• Review and approve GMP documentation (OOS, deviations, change controls) with strong technical judgment
• Develop and implement science‑driven strategies to optimize manufacturing processes and analytical methods
• Create and manage technical operations budgets, including OPEX and CAPEX

Senior Director – Technical Operations, Radioligand Therapies

Account Manager

• Responsible for account-based selling to health care providers (HCPs) who prescribe and influence the treatment for disease states represented in the Lilly dermatology portfolio
• Build relationships with key customers in the dermatology space to increase Lilly’s ability to drive adoption of new and existing therapies
• Identify and develop business relationships with state and local advocacy groups, teaching institutions, key influencers, and managed care organizations
• Develop a strong understanding of territory and reimbursement landscape and utilize appropriate business insights tools to analyze and adapt to business needs
• Navigate the ever-changing healthcare environment to understand accounts and impact key stakeholders to become a trusted partner
• Actively listen and adapt to verbal and non-verbal customer prompts throughout the call
• Demonstrate high learning agility to understand clinical information / disease state, product portfolio, and therapeutic marketplace
• Utilize selling model prior to and during conversations with customers to help them identify appropriate patients
• Collaborate effectively with others, both field-facing and internal peers to create a coordinated and positive customer experience

Pharmaceutical Sales, Territory Manager – Dermatology Specialty

Engineer

• Provide technical assessment and support for production operations in the areas of developing and sustaining process knowledge
• Offer process and equipment support, process optimization, equipment capability and asset management
• Serve as a process engineer supporting drug substance API manufacturing for biologics, oligonucleotide, peptide, and bioconjugate purification
• Perform impact and risk assessments for the relevant equipment
• Ensure processing equipment remains compliant with internal Quality System requirements and cGMP requirements
• Engage with: HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Maintenance, Environmental Monitoring, and Manufacturing
• Author, review, or approve high-quality technical reports and regulatory submissions
• Maintain records and technical notebooks adequately
• Develop or review plans and timetables for project work

Process Engineer, Purification

Product Marketing

• Provide scientific and technical leadership for GMP analytical testing activities
• Ensure analytical methods are fit for purpose and aligned with regulatory and lifecycle expectations
• Lead method readiness activities including method qualification, validation, transfer, troubleshooting, and ongoing lifecycle management
• Stay current with emerging analytical technologies and implement improvements to enhance efficiency, robustness, and compliance
• Ensure all laboratory testing operations comply with cGMP, GDP, and internal quality standards
• Maintain a constant state of inspection readiness; lead or support audits
• Own and manage quality events (deviations, investigations, CAPAs, change controls)
• Champion high quality data review and adherence to Good Documentation Practices
• Lead day to day GMP testing operations
• Oversee sample management, chain of custody, workflow prioritization
• Manage instrument and equipment lifecycle
• Drive continuous optimization of workflows
• Forecast, plan, and allocate personnel, equipment
• Manage laboratory inventory and ensure uninterrupted availability of critical materials
• Lead, coach, and develop a team of analysts and scientists
• Implement cross training to broaden team capability
• Drive deployment of new instruments, digital tools, and advanced analytical technologies

Advisor – GMP Testing Group

• Provides strategic and operational leadership for the raw material testing function within Analytical GMP Laboratories.
• Ensures timely, compliant, and scientifically sound testing of incoming raw materials that support manufacturing operations.
• Responsible for enabling high quality analytical performance and driving continuous improvement.
• Ensures full adherence to cGMP, global quality standards, and applicable regulatory requirements across all raw material testing activities.
• Maintains a state of continuous inspection readiness; leads internal and external audits and represents the function during regulatory inspections.
• Oversees deviation investigations, CAPA implementation, and upholds data integrity principles (ALCOA+).

Advisor – Raw Materials Testing, GMP Laboratories

Director

• Define and execute the vision for GMP microbiology and EM programs
• Provide microbiology SME guidance for site commissioning & qualification (C&Q) activities
• Serve as the microbiology SME for the Contamination Control Strategy (CCS)
• Develop modernization strategies including rapid microbiological methods, automated trending, and real-time EM reporting
• Ensure all EM and microbiology operations comply with cGMP, regulatory requirements, EHS standards, and global quality expectations
• Lead two core operational arms: Environmental Monitoring Program and Microbiology Testing Operations
• Partner with Manufacturing, QA, Engineering, Technical Services, and C&Q teams
• Lead and develop teams across both microbiology testing and EM operations
• Develop and present EM and microbiology performance metrics and quality risk indicators to site leadership

Director, Environmental Monitoring – Microbiology GMP Laboratories

• Lead all aspects of GMP analytical operations at the Lilly Medicine Foundry
• Oversee startup, scale-up, and steady-state operations, ensuring laboratory capability, GMP compliance, and digital enablement
• Drive lab design, commissioning, workflow optimization, and implementation of 5S systems
• Own GMP compliance, quality systems, and data integrity standards across all analytical operations
• Build and develop high-performing teams; lead hiring, onboarding, training, mentorship, and performance management
• Oversee instrumentation selection, URS development, and full lifecycle management (IQ/OQ/PQ, PM, calibration, troubleshooting, decommissioning)
• Manage capacity planning, scheduling, and laboratory inventories
• Ensure robust deviation management, investigations, and CAPA implementation
• Establish and maintain a strong safety and quality culture; lead HSE initiatives and hazard mitigation
• Partner with QA, Manufacturing, Engineering, Global QC, and R&D to support analytical technology transfer and method strategy

Director – Operations, GMP Laboratories

• Define and lead phase-appropriate, risk-based analytical strategies to support clinical manufacturing
• Develop integrated method readiness strategies, including validation and transfer across multiple modalities
• Oversee CMC analytical activities, specifications, stability strategies, and lifecycle elements
• Support digitalization initiatives and implementation of new technologies to enhance analytical workflows
• Drive adoption of PAT, automation, and high-throughput approaches for efficiency and compliance
• Champion continuous improvement initiatives and analytical lifecycle performance metrics
• Ensure alignment with GMP, ICH guidance, and regulatory frameworks throughout the product lifecycle
• Partner with QA, QC, Manufacturing, Engineering, and R&D to ensure analytical strategies support clinical and commercial objectives
• Act as a key liaison for technology transfer and method strategy across Foundry operations

Advisor, Projects & Strategy, Analytical

• Responsible for account-based selling to health care providers (HCPs)
• Build relationships with key customers in the gastroenterology space to increase Lilly’s ability to drive adoption of therapies
• Identify and develop business relationships with advocacy groups, teaching institutions, key influencers, and managed care organizations
• Develop a strong understanding of territory and reimbursement landscape
• Collaborate effectively with others to create a coordinated customer experience

Pharmaceutical Sales, Territory Manager – GI Specialty

Translator

• Oversee the successful transfer of API/DS processes from development to Foundry with a focus on purification and flexibility in supporting multiple modalities, including Biologics, ADCs, Tides, ensuring process fit to plant, scalability, and right-first-time execution.
• Apply scientific knowledge to troubleshoot production issues, identify areas for improvement, design and conduct lab studies, and implement new technologies or procedures.
• Monitor manufacturing processes, analyze experimental and production data, and author technical reports, protocols, and change controls.
• Support the creation and review of technical documents, batch records, process descriptions, and risk assessments, ensuring adherence to cGMP and regulatory standards.
• Work closely with various functions within Foundry and across PRD/CMC to achieve project goals and ensure product quality.
• Lead or assist in process-related investigations, assess deviations, design and conduct needed lab studies, and support Corrective and Preventive Actions (CAPAs) to maintain product quality and timelines.
• Provide scientific input during audits, provide on-floor support for critical operations, and mentor or supervise junior scientists or technicians in laboratory procedures, data analysis and related PTE activities.
• Collaborate with PRD, Process Engineering, and leverage internal/external/academic partnerships to accelerate innovation, including scouting, assessing, developing, and implementing new technologies.