Principal Scientist - Quality Control Chemical Testing Lab (m/w/d)

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. At Lilly in Germany, we are currently planning and building a high-tech production facility in Alzey (Rhineland-Palatinate), which will expand our production of injectable drugs from 2027 and employ up to 1,000 specialists. To make the most of our innovative production site, we are looking for motivated reinforcements who, together with us, will ensure the supply of Lilly medicines in Germany, Europe, and worldwide, in line with the three Lilly values of "Excellence," "Integrity," and "Respect for People." Join our Lilly team in Alzey and start as soon as possible as: Principal Scientist - Quality Control Chemical Testing Lab (m/w/d) You need to make sure of: Timeliness: Ensure work is completed in a timely manner to support batch release and site priorities. Safety and GMP Compliance: Adhere to Environmental Health and Safety (EHS) requirements and laboratory safety procedures. Maintain cleanliness and contamination control, in alignment with cGMPs, chemical hygiene, and biosafety guidelines. Compliance and Documentation: Execute activities in compliance with applicable standard operating procedures (SOPs), methods/protocols, good documentation practices (GDP), and regulatory guidelines. Data Recording and Data Integrity: Execute activities in accordance with data integrity standards and ALCOA principles. Data Review: Perform data review, as assigned, to ensure accuracy and compliance. Deviation Identification and Investigation: Identify and escalate any atypical results and potential deviations. Participate in root cause analysis for laboratory investigations and implement corrective/preventive actions, as required. Provide data to support manufacturing investigations, as required. Continuous Improvement: Identify and communicate opportunities for improvement. Cross-functional Participation: Participate in cross-functional teams (e.g., process team, global working teams, etc.), as required. Training and Mentorship: Maintain training competencies and only execute work where qualified. Participate in training and mentorship, as requested. Audit and Inspection Support: Execute activities in a compliant manner that supports an ongoing state of inspection readiness. Participate in pre-inspection reviews/checks and provide on-site support during audit/inspections, as requested. What tasks await you? Holistic Data Review and Release: Perform comprehensive data reviews and prepare certification documents, as required, including but not limited to Annual Product Review, method and process performance, Periodic Management Reviews Method Transfer and Validation : Participate in method transfers and validations, as required (e.g., author change control, protocol, participate in transfer/validation technical meetings, assist in transfer/validation execution, etc.). Strategic Technical Leadership: Provide high-level technical direction and strategy for the QC laboratory, leveraging deep expertise to guide the development and continuous improvement of testing methods, quality systems, and analytical capabilities. Serve as a technical authority in complex decision-making forums and contribute to the long-term roadmap for QC infrastructure and innovation. Ensure QC strategies align with broader manufacturing and regulatory expectations, anticipating future trends and positioning the lab to meet evolving business needs. Problem Solving & Innovation: Lead the resolution of highly complex QC technical challenges. Apply advanced scientific knowledge and creative thinking to address issues spanning multiple disciplines (analytical chemistry, automation, data systems). Design and implement novel solutions or improvements to enhance accuracy and efficiency across the QC operation. Utilizes technical skills to lead or perform deviations and in-depth investigations into out-of-spec results and aberrant data. Draw conclusions and perform root cause analysis investigations and recommend solutions to prevent recurrence. Develop investigational testing protocols and perform testing as required. Cross-Functional Influence: Collaborate and influence across multiple functions (Manufacturing, Quality Assurance, Regulatory, Product Development) to ensure QC considerations are integrated into broader business decisions and initiatives. Act as the key QC representative on cross-functional teams and ensure quality control requirements and risks are clearly understood and addressed by stakeholders. Use t