Senior Director TS/MS – Oral Solid Dose

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

About the Katwijk Site

Eli Lilly is investing €2.6 billion in a new state-of-the-art manufacturing facility in Katwijk, Netherlands. This facility will produce oral medicines for cardiometabolic health, neuroscience, oncology, and immunology, incorporating next-generation manufacturing technologies including dock-to-dock automation, paperless manufacturing, and process analytical technology while achieving carbon neutrality and zero waste to landfills.

Timeline: Construction begins 2026, completion targeted 2029-2030.

Position Overview

A senior leadership role responsible for the technical strategy and process excellence of drug product manufacturing at an Oral Solid Dosage manufacturing site. This includes technical oversight for drug product intermediates control strategy from spray dried dispersion through tablet and capsule manufacturing. Serves as the site’s authority on technology transfer, scale-up, and manufacturing science for oral solid dose forms (tablets, capsules).

Key Responsibilities

Technical Strategy & Leadership

• Define and lead the site's technical agenda and strategic direction for medium and long-term planning
• Develop and execute plans aligned with corporate goals and future product pipelines
• Participate as a key member in setting strategic direction for the manufacturing site
• Develop recruitment & start up strategies for areas under his/her responsibilities, ensuring the Site is delivered without accidents, compliant, on budget and according to schedule

Technology Transfer & New Product Introduction

• Oversee the transfer of new oral solid dose formulations from development into commercial production
• Ensure smooth tech transfers from R&D to manufacturing, guiding scale-up from lab/pilot scale to full production
• Conduct equipment fit assessments and process characterization
• Ensure processes are robust at commercial scale

Process Optimization & Validation

• Ensure all tablet/capsule manufacturing processes are optimized and remain in a validated state
• Drive continuous improvement of granulation, compression, coating processes to improve yields and efficiency
• Lead process validation, including initial process qualification for new products
• Oversee ongoing continued process verification to meet cGMP requirements
• Solve processing issues and enhance operational efficiency

Quality Compliance & Troubleshooting

• Guarantee GMP compliance and regulatory readiness of all technical operations
• Define control strategies for critical quality attributes including drug product intermediates from spray dried dispersion, blend uniformity, tablet hardness, and dissolution profiles
• Support preparation of regulatory submissions
• Provide front-line scientific support for troubleshooting manufacturing issues and investigations
• Drive risk management and CAPA initiatives

Cross-Functional Collaboration

• Build strong technical partnerships with Formulation Development/R&D, Global TS/MS network, Operations, Quality, Engineering, and external partners
• Represent TS/MS in site leadership forums and decision-making committees
• Ensure technical considerations shape business decisions
• Liaise with Contract Manufacturing Organizations as needed

Documentation & Reporting

• Oversee generation and timely completion of all technical documents and reports
• Ensure compliant documentation including process development reports, validation documentation, technical protocols, and annual product reviews
• Maintain audit readiness and knowledge management standards

Team Development & Leadership

• Lead and mentor the TS/MS team of scientists and engineers
• Ensure the organization has appropriate capability and capacity through recruiting and developing talent
• Allocate resources effectively and build a culture of technical excellence
• Coach team members, manage performance, and prepare future technical leaders

Qualifications and Requirements

Education

• Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences or related field (strongly preferred)
• Master's degree acceptable with significantly higher experience

Experience

• Experience: Minimum 10 years in production, engineering, technical services, or supply chain (At least 10 years in the pharmaceutical or chemical synthesis industry with a strong focus in manufacturing operations); 5 of those years should be in management positions)
• 15+ years in pharmaceutical manufacturing and development roles
• Significant leadership experience in TS/MS, MS&T, Process Development, Tech Services, or Manufacturing Science functions
• Prior roles in technical support of manufacturing, leading tech transfer projects, validation, or process engineering
• Progressive responsibility with experience managing large technical teams or projects
• Preferred: Experience in API manufacturing, spray dried dispersion (SDD) processing, or chemical plant manufacturing environments. Candidates combining chemical plant manufacturing experience with OSD expertise are particularly well-suited for this role

Technical Expertise

• Subject matter expertise in drug product manufacturing
• In-depth knowledge of OSD processes: blending, granulation (wet/dry), tablet compression, coating, and capsule filling
• Fluency in process validation, scale-up principles, and Quality by Design (QbD)
• Knowledge of regulatory guidelines for oral solid dose production
• Experience troubleshooting and improving OSD processes (content uniformity, coating optimization, etc.)
• Expertise in technology transfer and regulatory compliance
• Preferred: Knowledge of spray dried dispersion (SDD) processes, API manufacturing, or process-scale manufacturing (PSM) operations

Leadership & Soft Skills

• Strategic thinking and decision-making abilities
• Excellent stakeholder management and cross-functional collaboration skills
• Ability to influence teams and articulate technical issues in business terms
• Strong communication abilities for interfacing with senior leaders, global functions, and regulators
• Capability to manage changing priorities under tight timelines
• Cultural leadership to drive operational excellence

Additional Requirements

• Fluent knowledge of cGMP regulations
• Experience participating in regulatory inspections or audits
• Experience with Continuous Improvement methodologies (Lean/Six Sigma) applied to manufacturing science
• Willingness to travel and collaborate globally (~5% travel)
• Ability to interface with other manufacturing sites and development labs

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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