Scientist – Quality Control Stability Program and Supply Chain (m/w/d) Full-time

Scientist – Quality Control Stability Program and Supply Chain (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.”

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?

• Sample and Retains Management: Oversee the process of sample and retains receipt, sample aliquot, sample and retains storage and sample disposal to ensure that they are compliant with Lilly Global practices and regulatory requirements.
• Sample Prioritization and Scheduling: Review sample requests to determine priority levels. Identify time-sensitive samples, as required. If a required sample is not received as expected, proactively reach out to the sample submitter or manufacturing contact to inquire and resolve discrepancies.
• Collaboration: Participates in QC scheduling meetings and huddles, as required, providing updates on sample management to ensure alignment and timely resolution of issues.
• Stability Study Planning and Initiation: Collaborate with global team and third-party labs to plan stability studies in alignment with regulatory commitments, product specifications, annual stability program requirements, and response to non-routine situations such as deviations.
• Sample Coordination & Inventory Management: Coordinate collection, receipt, and storage of stability samples. Partner with Manufacturing and Warehouse to ensure stability sample pulls are completed and delivered to QC or third-party labs on time. Ensure samples are stored in the appropriate condition and stability sample inventory is maintained.
• Stability Pulls & Testing Coordination: Ensure stability pulls are scheduled and executed in accordance with procedures. Track stability testing progress with QC/third-party labs and address delays and/or constraints.
• Data Review and Monitoring: Oversee stability data and conduct time point results reviews, as required. Analyze stability trends to evaluate ongoing stability profiles, as required, and leverage statistical tools to identify potential changes and provide input on shelf-life. Address out of trend data in accordance with procedures and support proactive decision-making (e.g., investigation, additional testing, etc.). Compile stability summary reports, as needed (e.g., for inclusion in annual product review, data package to support shelf-life extension, etc.)
• Holistic Study Review & Completion: Perform a comprehensive final review of stability studies once all scheduled points have been executed and prepare final reports, as required. Coordinate disposal of remaining inventory, as required.
• Management of third-party labs: Manage and oversee third-party labs on stability program.

How do you convince us?

• Bachelor's degree or associate's degree in chemistry, Biology or other science disciplines with practical experience in GMP related field are preferred
• Minimum of 3 years of regulated industry experience in QC with demonstrated knowledge of related quality systems and regulatory requirements
• Hands-on experience in stability program management.
• Experience in working with LIMS
• Written and oral skills in German and English
• Participated in Regulatory inspections as a SME such as EMA, FDA, etc.
• Management experience on third-party laboratories is a plus.

Additional Information:

• Primary location is Alzey
• On-site presence required

What can you look forward to with us?

• Pioneering spirit: Become part of a team of specialized professionals that will grow to up to 1,000 colleagues over the next three years.
• Innovation: You will work in a medical high-tech production facility equipped with the most advanced technology.
• Creative freedom: From the beginning, you will have the freedom to contribute your ideas and implement them in cross-functional teams.
• Development: We value the individual career development of our employees and ensure fair access to professional development worldwide through our “Corporate Lilly University.”
• Financial benefits: In addition to your attractive salary, we offer you the option of an excellent company pension plan and other individual benefits.

Have we piqued your interest? Then please apply online with your complete application documents through our applicant portal.

We look forward to your application!

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 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.

#WeAreLilly