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 technical credibility and data-driven insights to gain support for QC-driven improvements or resources at the site and global levels.
Regulatory Interface: Serve as a SME during regulatory inspections and audits, addressing complex technical questions and defending the scientific rationale of methods. Interface with global health authorities or industry groups as needed, contributing technical expertise to compliance responses or guidance discussions.
Mentorship and Talent Development: Elevate the technical capabilities of QC staff by mentoring scientists and technicians on advanced concepts and problem-solving techniques. Share specialized knowledge in new and emerging technologies, ensuring the team stays current and competent.
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?
Sampling: Sample in-coming goods in accordance with the sampling plan. Sampling of in-coming goods may include operations in a biosafety cabinet/laminar airflow in the cleanroom environment.
Sample Handling: Handle samples in accordance with local procedures to prevent contamination.
Sample Collection and Labeling: Label samples and document sample collection in accordance with local procedures.
Sample Transport: Carefully transport samples to the identified area in a timely manner, in accordance with local procedures.
Communicate with Warehouse and QA: Communicate clearly with Warehouse and QA and work together to ensure samples are collected in accordance with the approved sampling plan.
Sample testing: Perform testing on incoming goods in accordance with established laboratory procedures and GMP requirements, including but not limited to excipients, printed packaging materials, and so on. Techniques may include Raman, Eye-C, and so on.
Equipment usage: Perform routine checks and cleaning on equipment in accordance with established methods/procedures. Immediately report equipment malfunctions and coordinate required calibration or maintenance with the QC equipment team.
Method Support: Support and execute method transfer, verification/validation, and provide ongoing technical support for analytical methods and technology of incoming goods, as required.
How do you convince us?
Master’s degree, or Bachelor in Analytical Chemistry, Chemistry, or Biology with extensive practical experience in GMP related field is preferred
Minimum of 5-10 years of regulated industry experience in QC with demonstrated knowledge of related quality systems and regulatory requirements
Hands-on experience in Chemical testing and relevant method validation/transfer per ICH guideline, including HPLC and UV-Vis
Experience in working with Empower, LIMS and LES
Written and oral skills in German and English
Participated in Regulatory inspections as a SME such as EMA, FDA, etc.
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 (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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