Senior Manager Chemical Testing

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:

Senior Manager Chemical Testing (m/w/d)

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future.  As a result, Lilly is looking for experienced quality assurance associates to support our growth in Alzey, Germany. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

Senior Manager Chemical Testing is primarily responsible for managing chemical testing activities in support of Parental Manufacturing, Device Assembly and Packaging facility in Alzey site.

Responsibilities / Key Objectives and Deliverables  

• 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: Lead activities in compliance with applicable standard operating procedures (SOPs), methods/protocols, good documentation practices (GDP), and regulatory guidelines.

• Data Recording and Data Integrity: Lead activities in accordance with data integrity standards and ALCOA+ principles.

• Data Review: Manage 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.

Responsibilities

• Operational Management: Oversee and coordinate QC Chemical Testing activities to meet production and supply needs. Proactively manage workload for on-time delivery. Actively engage with QC personnel (e.g., monitoring QC activities, answering questions, resolving issues, leading/participating in huddles). Adjust resources, as needed, to maintain smooth QC operations and meet timelines. 

• Issue Oversight: Engage directly with personnel to address atypical results, equipment malfunctions, or other operational problems. Anticipate potential problems, take proactive action, and seek assistance/escalate, as needed. 

• Team Performance Management & Development: Supervise the Chemical testing team, providing clear directions and expectations for their work. Set objectives and development plans, aligned to departmental goals and individual growth. Monitor performance and provide ongoing coaching and feedback. Conduct regular one-on-one check-ins to discuss progress, acknowledge accomplishments, and address performance gaps. Recognize and celebrate high performance, build morale, and handle employee relations issues in a fair and timely manner. Partner with upper management and/or HR on personnel matters, as needed, but resolve minor issues directly through guidance and feedback. Foster a positive team environment built on trust, accountability, and continuous learning. 

• Cross-Functional Collaboration: Serve as the key liaison between QC and other site functions, when requested. Represent the QC function in cross-functional meetings.

• Global Network & Best Practices: Share and adopt best practices, standardized processes, and lessons learned to drive consistency and operational excellence in QC operations.

• Audit Readiness & Issue Resolution: Ensure QC area is ready for inspection. Participate in self-inspection and inspection readiness activities. Proactively address compliance gaps.

• Financial Responsibilities: Manage laboratory costs, including management of purchase orders and approval of invoices, as requested.

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

• Sufficient qualification for Head of Quality Control

• Minimum of 5-10 years of regulated industry experience in QC with demonstrated knowledge of related quality systems and regulatory requirements

• Hands-on and Management 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, ideally also in LIMS introduction

• People management

• Written and oral skills in German and English

• Participated in Regulatory inspections such as EMA, FDA, etc.

• Management experience of third-party laboratories

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.

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