Senior Principal Scientist, Quality Control - Laboratory Informatics

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.

Position Overview:

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.

The Senior Principal Scientist, Quality Control – Laboratory Informatics, serves as a business representative for laboratory IT systems and is responsible for mentoring and educating peers on the use of lab systems. This role also provides support for regulatory audits, Management review of the laboratory Quality System, laboratory metrics, and laboratory documentation.

Responsibilities:

• Maintains responsibility for a safe work environment, leading safety initiatives, and working safely; accountable for supporting all Health, Safety, and Environmental Corporate and Site Goals.
• Performs or supports the laboratory with the validation of laboratory equipment and software systems.
• Supports the establishment and maintenance of the validated state of software-based computerized systems in use in the lab.
• Ensures data integrity by design within the QC laboratory.
• Leads site deployment and upgrade of QC laboratory IT systems such as Empower, NuGenesis, and Labvantage.
• Partners and builds relationships with Global Quality Laboratory Network and Global IT team members.
• Acts as business owner and contact subject matter expert for QC laboratory IT systems
• Collects data and authors management review documents for the laboratory quality system
• Provides oversight and supports continuous improvement of quality systems as they relate to the QC lab.
• Applies knowledge of quality principles, cGMP, and laboratory systems towards the development and execution of local procedures, training courses, and practices.
• Assists in improvement of quality systems by creating or revising worksheets, developing or updating laboratory execution system documentation, updating laboratory methods, and maintaining other lab documentation systems.
• Manages and supports audit and inspection activities for the laboratory.
• Manages methods in the QC Laboratory.
• Performs and mentor’s others in change control, analytical investigations, root cause investigations, and activity planning.
• Implements and complies with corporate, site, and laboratory safety standards.
• Develops training materials.
  

Basic Requirements:

• Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
• Minimum 6 years in the pharmaceutical industry with specific Quality Control and laboratory computer system experience.
• On-site presence required.

Additional Skills/Preferences:

• Fluent in English and German.
• Demonstrated understanding of cGMP regulations.
• Previous experience in GMP production environments.
• Proficiency with applicable computer systems.
• Deep understanding of compliance requirements and regulatory expectations
• Demonstrated accuracy and proficiency in analytical skills.
• Proficiency with computer systems including Microsoft Office products, LIMS, Laboratory Execution Systems, chromatography systems, electronic laboratory notebook systems including implementation of systems.
• Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.
• Excellent written and oral communication skills
• Previous LEAN experience: ability to drive continuous improvement.
• Experience operating or implementing Lab IT systems including LIMS and Automated Lab Execution systems.
• Strong technical aptitude and ability to train and mentor others.
• Project management experience.
• Demonstrated problem-solving and decision-making capability.
• Demonstrated technical writing skills
• Understanding of statistical tools and analyses.
• Strong documentation skills and attention to detail.
• Demonstrated strong oral and written communication skills.
• Demonstrated interpersonal skills and the ability to work as a team.
• Root cause analysis/troubleshooting skills.
• Demonstrated attention to detail and ability to maintain quality systems.
• Proven ability to work independently or as part of a Team to resolve an issue.
• Previous regulatory inspection readiness and inspection execution experience.

Additional Information:

• Primary location is Alzey, Germany.
• Ability to travel (approximately 10%).
• Ability for Short Term Assignment (6-9 Months) in a Parenteral Products Network (PPN) established manufacturing site prior to starting the role.
• Ability to work overtime as required.

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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