Principal Scientist - Quality Control Compliance

at  Lilly

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.
Lilly is currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This facility will be Lilly’s most technically advanced manufacturing site and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance. This is a unique opportunity to be a part of the technical team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the technical capabilities to enable a successful startup of cGMP manufacturing operations.

BASIC REQUIREMENTS:

• Hons Degree Qualified – B.Sc. in Analytical Chemistry, Chemistry / Biochemistry, Microbiology, Molecular Biology, or related discipline, with a minimum of 5 years relevant GMP experience.

ADDITIONAL SKILLS/PREFERENCES:

• Strong written and oral communication skills.
• Excellent attention to detail.
• Ability to work independently, self-sufficiently, and pro-actively in the performance of work duties.
• Ability to influence others to implement changes in the minimum time.
• High learning agility and flexibility to achieve the required outcomes.
• Imaginative approach to problem solving and solution discovery.

• Interpret regulatory requirements and global quality standards to develop and maintain local paper free, digital enabled systems, processes and procedures. Ensure internal and external compliance requirements including data integrity requirements are incorporated into the lab systems and processes.
• Monitoring of GMP and compendial compliance.
• Own the GMP readiness plan for the labs to ensure a consistent and compliant approach across all laboratories during start up.
• Design, implement, maintain and own the analytical equipment lifecycle management process including oversight of third-party service providers providing support for equipment lifecycle activities. Review GMP documents associated with equipment qualification and calibration including DQ/IQ/OQ/PQ documents for analytical equipment and associated utilities.
• Implement the QCL Training / Personnel Qualification Strategy for start-up and subsequent phases ensuring alignment with site policies and procedures.
• Serve as QC SME for lab processes such as equipment qualification, lab investigations, personnel qualification etc.
• Work with central functions in the development and delivery of standardised processes and procedures in QC.
• Perform / support change controls, deviations and root cause investigations. RCI SME/ mentor for QC.
• Identify and implement appropriate CAPAs.
• Author/review key GMP documents such as GMP standard operating procedures, training materials, test methods, qualification documents, lab/ equipment/ computer system periodic reviews, annual product reviews, validation master plans etc.
• Process owner for lab specific GMP service providers.
• Lead the QC inspection readiness program.
• Support and participate in self-inspection or other audits with particular reference to the analytical aspects of cGMPs as defined by the Health Authorities, and Food and Drug Administration.
• Collate QC compliance metrics and make recommendations to management on actions.
• Provide ongoing education, coaching, feedback and mentoring to QC personnel as it relates to execution of quality systems.
• Serve as QC Quality risk management facilitator and SME.