Scientist - Quality Control Stability Program and Supply Chain; m​/w​/d

Position: Scientist - Quality Control Stability Program and Supply Chain (m/w/d)
Location: Germany

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:
**** Scientist - Quality Control Stability Program and Supply Chain (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.
* * 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…