TSMS Principal Scientist

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
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.
Position OverviewTS/MS Role
The TS/MS Scientist provides technical support to pharmaceutical manufacturing processes, owning the process control strategy and all associated technical documentation. They proactively identify and lead process improvement initiatives focused on productivity and quality, evaluate the technical impact of changes to process steps, materials, equipment, and facilities, and lead new product introduction activities.
Working in close collaboration with manufacturing and cross-functional teams, they ensure all technical activities remain aligned with applicable procedures, regulations, and regulatory commitments, while also mentoring fellow process scientists.
This position starts with a 12-month contract, with the intention of offering a permanent contract based on mutual fit. (Dienstverband: tijdelijk met uitzicht op vast)
Key Responsibilities
Core Process Ownership
Own and maintain Process Flow Documents (PFDs), manufacturing tickets, instructions, formulas, and Bill of Materials (BOM)
Define and maintain the Process/Product Control Strategy, including process monitoring plans
Know and apply critical process parameters (CPPs), process constraints, and sources of variability
Know in detail the product development history document, understanding its trajectory and key technical aspects
Ensure all documentation is accurate, current, and reviewed without impacting the production schedule
Daily Manufacturing Support
Provide technical support to manufacturing processes — including troubleshooting, technical decision-making, and product impact assessments
Support documentation needs such as test tickets (TSA), control charts, and statistical analyses
Train and mentor operators and other scientists on manufacturing instructions, processes, and monitoring plans
Deviation & Investigation
Investigate deviations and lead root cause analysis using problem-solving tools (FMEA, etc.)
Own and lead technical investigations related to products and manufacturing processes
Process Improvement & Performance
Proactively analyse process performance data from monthly reports, like annual product reviews nd deviation trends
Lead improvement projects focused on productivity, quality, and continuous improvement
Implement process changes as required
Change Control & Validation
Evaluate change proposals for technical impact across process steps, materials, equipment, facilities, and utilities
Define and lead validation and revalidation strategies in compliance with current procedures
New Product Introduction, Technology Transfer & Development
Lead new product introduction and technology transfer activities
Prepare the plant to receive new products prior to development activities
Lead development activities and subsequent documentation
Perform sampling (blend uniformity, in-process tests) and prepare sampling plans for process validation and cleaning
Assist in the manufacture of TS/MS-related batches (TSA, experimental, registration, and development batches)
Coordinate across development, manufacturing, and other impacted areas using product transfer tools and business procedures
Regulatory Compliance
Apply regulatory requirements governing manufacturing processes (NDAs, FDA guidelines, local and corporate standards)
Ensure all technical activities align with applicable procedures, regulations, and regulatory commitments
Stakeholder Engagement
Serve as the technical representative in Process Teams and relevant business forums
Engage with local and global technical networks for supported products
Participate in product-related meetings such as G-PLOTs and technical networks
Educational Requirements
Bachelor’s degree related to Science, Pharmacy, or Engineering and/or Master’s degree in a related area such as Industrial Pharmacy.
Experience Requirements
Five (5) years in solid dosage manufacturing and/or spray dryer dispersion.
Other Requirements
Excellent oral and written communication in English.
Excellent technical documentation skills.
Ability to work irregular hours, rotating shifts, weekends, and holidays, if necessary.
Excellent communication skills at all levels (with both internal and external resources).
Self-initiative.
Project management skills.
Knowledge and application of statistical tools and software used as statistical tools.
High technical curiosity.
Expected Start Date: 4 January 2027
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.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$ - $
Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly