Responsible Scientist – Quality Control Microbiology Lab (m/w/d) Full-time

Responsible Scientist – Quality Control Microbiology Lab (m/w/d)

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:

The Responsible Scientist utilizes their technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvement, and completes thorough investigations of aberrant data and results. Outcomes of these activities including results, conclusions, and action plans are thoroughly and accurately documented by the Responsible Scientist and may be published in regulatory and/or technical documents. The position is responsible for technical mentoring of lab staff, sharing technical information and best practice within the work group and across plant sites.

Responsibilities / Deliverables:

• Technical review, interpretation, and release of raw material, in-process, and finished product data.
• Contributes to annual product reviews and process validations as required.
• Perform technical training and mentor analysts through formal process/program.
• Initiate, author, and review change controls and deviations.
• Utilizes technical skills to lead or perform in-depth investigations into out of spec results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence.
• Develop investigational testing protocols and perform testing as required.
• Author and assist in execution of method verifications, transfers, and validations.
• Monitor method and process performance.
• Improve lab quality systems; develop content, review, and approve SOPs and training as necessary.
• Contribute to development and implementation of Global Lab Quality Standards.
• Comply with and implement safety standards.
• Provide technical oversight for Periodic Management Reviews.
• Interacts effectively with business partners to communicate and resolve issues and gain a clear and accurate understanding of each other's requirements.
• Types of communication include: Notification to management of quality issues.
• Interaction with other functions and auditors.
• Participation in internal/external audits.

How do you convince us?

• Master's or bachelor's degree with extensive relevant work experience in a science field related to microbiology.
• 5-10 years of demonstrated relevant experience in a GMP, Microbiology Laboratory, preferably associated with GMP manufacturing.
• Demonstrated proficiency in laboratory analysis including, but not limited to endotoxin, bioburden, sterility, bioassay, particulate matter, and organism identification.
• Strong oral and written communication skills and demonstrated through documentation and presentation skills
• Fluent in English & German

Additional Information:

• Primary location is Alzey, Germany
• Ability to travel (approximately 10-20 %)
• 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.

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. 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.