Requirements: English
Company: TN Italy
Region: Sesto Fiorentino , Toscana
Social network you want to login/join with:Sr. Principal Scientist - Drug Product External Manufacturing TS/MS Sterility Assurance, Sesto FiorentinoClient: LillyLocation: Sesto Fiorentino, ItalyJob Category: OtherEU work permit required: YesJob Reference: c59b3d2baf8eJob Views: 2Posted: 06.05.2025Expiry Date: 20.06.2025Job DescriptionWere looking for people who are determined to make life better for people around the world.ResponsibilitiesProvide oversight, assistance, and guidance to Contract Manufacturers (CMs) and DPEM team members for parenteral quality assurance activities, focusing on micro and sterility assurance.Support operational control strategies, resolve complex deviations, and lead projects to improve technical capabilities.Guide primary loop activities related to micro and sterility assurance, ensuring compliance with quality policies and cGMP regulations.Mentor and provide technical oversight to primary loop TS/MS representatives.Monitor contract manufacturing performance, identify concerns, and escalate with recommendations.Understand manufacturing principles for parenteral drugs, including chemistry, equipment, aseptic processes, and container systems.Use risk management to evaluate manufacturing processes for microbial, endotoxin, and particulate contamination risks.Provide technical guidance for sterility assurance programs and investigations.Review sterility assurance at CMs in collaboration with QA SME.Ensure regulatory and technological oversight, assess capabilities of CMs, and lead risk assessments.Develop and review technical documents and change controls related to sterility assurance.Stay current with industry trends and regulatory expectations.Develop networks within Lilly and with external partners to support investigations and standards compliance.Develop strategies to ensure CMs are aligned with industry standards.Improve DPEM capabilities and define technical standards for CMs.Review and assess standards, and participate in local procedure creation and training needs assessment.Present GQS400 reviews annually and monitor sterility metrics for trends.Contract Manufacturing SupportSupport deviations, change controls, microbiological data, CAPA, validation, and technical reports.Guide CMs in resolving technical and quality issues, review deviations and change controls, and lead critical deviations.Keep management informed, contribute to reports, and participate in performance reviews.Support new product and CMs implementation, and assess new CMs for Lilly standards compliance.Define qualification and validation protocols, provide technical leadership, and support continuous improvement.RelationshipsContract manufacturing teams, Lilly TSMS, QA, global parenteral sites, and external networks.Basic QualificationsBachelors degree in Microbiology, Pharmacy, or Chemistry with 8+ years in technical/quality roles in parenteral manufacturing, orPhD in Microbiology with 2+ years in similar roles.Additional Skills/PreferencesNetworks, Lilly systems experience, micro/sterility testing knowledge, leadership skills, cultural awareness, communication, and problem-solving skills.Additional InformationDay shifts with possible off-hours, up to 30% travel, onsite presence required.Lilly is an EEO/Affirmative Action Employer. We support employee resource groups such as Africa, Middle East, and others, fostering diversity and inclusion.#J-18808-Ljbffr