Scientist – Sterility Assurance - Technical Services/manufacturing Science (m/w/d)

Scientist – Sterility Assurance - Technical Services/Manufacturing Science (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."

Responsibilities:

The Sterility Assurance Scientist is a technical role that assists in development and implementation of the site's sterility assurance programs and provides technical guidance and expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies, including disinfectant efficacy. The principal role is a position that develops and implements a technical agenda and is responsible for providing technical leadership for the Parenteral Process Team. The principal role is also expected to serve as a mentor within the TSMS team and engage in upstream and external to site activities related to sterility assurance.

Key Objectives/Deliverables:

• Ensure and provide oversight and technical guidance for sterility assurance programs at the manufacturing floor level.

• Lead or provide technical oversight for Provide technical support for activities related to sterility assurance programs including but not limited to:

• Airflow Pattern Testing

• Environmental Monitoring Performance Qualifications

• Aseptic Process Simulations

• Cleaning, Sanitization, and Disinfection

• Gowning within GMP Classified Areas

• Aseptic Processing Techniques

• Contamination Control

• Assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established.

• Lead or assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established.

• Lead/assist with support and/or provide technical expertise for developing the site's contamination control strategy and cleaning and sanitization program/strategy, and disinfectant efficacy strategies.

• Lead/assist with support and/or provide technical expertise for the facility's cleanroom gowning and aseptic technique strategy/program.

• Knowledge in pharmaceutical Microbiology, related to microbiological media, microbiological enumeration techniques, and microorganism isolation and identification.

• Lead/provide technical oversight for one or both the Environmental Monitoring (EM) or Aseptic Process Simulation (APS) program:

• Authoring EM Performance Qualifications (EM PQ) and overseeing the execution.

• Evaluating EM data and authoring EM Trend Reports.

• Assist with identifying facility environmental isolates and how to create and maintain environmental isolate cultures.

• Authoring APS protocols and overseeing the execution.

• Evaluating the APS data, including personnel qualifications, and authoring APS reports.

• Assist with tracking and tending APS to ensure all regulatory requirements and Global Quality Standards are met for each manufacturing line/process.

• Apply sterility assurance risk management to evaluate manufacturing processes and associated controls with respect to potential introduction of microbial, endotoxin, and particulate contamination.

• Analyze microbial and manufacturing data to identify trends, process discrepancies, and opportunities for continuous improvements.

• Lead or provide technical support for root cause investigations associated with sterility assurance programs.

• Participate and/or provide technical sterility assurance support during internal and external audits.

• Create, execute, review, and/or approve technical documents and change controls related to sterility assurance programs.

• Work within cross-functional teams to implement TS/MS objective and deliver on business and quality objectives.

Basic Qualifications:

• Bachelor's or Master's Degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline.

• Demonstrated understanding and relevant experience of scientific principles required for manufacturing of parenteral drug products within operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance associated cGMP pharmaceutical manufacturing.

• (Senior) 2+ years in pharmaceutical manufacturing (Microbiology, TSMS, Sterility Assurance, or related dept).

• (Principal) 5+ years in pharmaceutical manufacturing (Microbiology, TSMS, Sterility Assurance, or related dept).

Additional Skills/Preferences:

• Possess strong interpersonal skills to work cross-functionally within a team.

• Possess strong self-management and organizational skills.

• Possess strong oral and written communication skills for communicating to colleagues, management, and other departments.

• Experience with data analysis and trending.

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. 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.