Jerneja Mori, PhD, MBA

Experience

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  Kemijski Inštitut - National Institute of Chemistry

  Oct 2009 - Feb 2014

  As post-doctoral researcher I was working in the field of innate immunity and synthetic biology. I was working with techniques like:- mammalian cell culture (HEK293, macrophage)- bacterial fermentation process and protein production and purification- recombinant DNA techniques (PCR, cloning, transfection, protein expression)- ELISA, SDS-PAGE, western blot, etc.- Mentoring iGEM 2010 student team and several students for their graduate thesis- Leading practical class for Microbiology with epidemiology at the Undergraduate program Cosmetic, VIST Ljubljana Show less As PhD student I was working in the field of innate immunity and synthetic biology. I was working with techniques like:- mammalian cell culture (HEK293, macrophage)- bacterial fermentation process and protein production and purification- recombinant DNA techniques (PCR, cloning, transfection, protein expression)- ELISA, SDS-PAGE, western blot, etc.- in vitro and in vivo testing of vaccines- Mentoring iGEM 2010 student team and several students for their graduate thesis- Leading practical class for Microbiology with epidemiology at the Undergraduate program Cosmetic, VIST Ljubljana Show less

  • Postdoctoral Research Assistant

    Jun 2013 - Feb 2014

  • Researcher, PhD Student

    Oct 2009 - Jun 2013
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  Novartis

  Mar 2014 - Jan 2018

  As Quality Control Manager in microbiology laboratory I was responsible for:- managing laboratory analysis, - validation and implementation of new methods/analysis in the field of environmental monitoring (EM), - interpreting results, data analysis and writing reports (annual and monthly reports for EM)- writing GMP relevant documents (SOPs, analytical protocols and reports, risk assessments, FMEA analysis),- solving deviations, implementing preventive and corrective actions, - in lead for new projects and improvements (for example: paperless implementation in QC lab for EM samples, upgrade of EM program in Novartis Slovenia, upgrade of IT system for EM trending), - involved in inspection audits (FDA and others).I am daily managing the team responsible for laboratory analysis (3-4 associates), working together with QA units and production plant on different projects, training of operators in production and quality control unit. Show less

  • Quality Control Manager

    Oct 2015 - Jan 2018

  • Quality Assurance Manager

    Mar 2014 - Oct 2015
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  Thermo Fisher Scientific

  Feb 2018 - Mar 2020

  - QC Manager in CDMO for production of Biologics for clinical I-III phase and commercial manufacturing by using single use technology.- Leading and coordinating QC department of >45 associates with sub departments: Microbiology, Biochemistry I and II, Support and QC scientist. - The team is responsible for Raw material sampling and testing, microbiology testing (bioburden, endotoxin, Environmental / water / gas monitoring), biochemistry testing (UPLC, HPLC, ELISAs, concentration testing, cIEF, CE-SDS, etc), safety testing, stability program and reference standard management, validation / qualification and tech transfer of analytical methods, etc.- Responsible for meeting project goals, team KPIs and managing resources and department budget. - Defining yearly department goals, development plans and optimization projects and implementation of lean lab concept.- Overseeing daily team operations within QC department and collaborating with other departments in order to support day to day activities.- Implementing lean lab initiatives and continuous improvement projects in order to increase efficiency and lower costs.- Making sure analysis are being performed in compliance with cGMP and regulatory requirements. - Frequent interactions with customers, external vendors and laboratories- Managing OOS / OOL/ OOT, deviations, change management, CAPA and laboratory investigations.- Supporting regulatory and customer audits and customer visits (7 successfully completed PAI including FDA and many customer audits).- Collaboration with other sites within Thermo Fisher network and global functions.- Review of QA agreements, customer proposals, SLA and other Contractual work.- Development of employees, coaching and training support. Show less My main responsibilities while working in highly dynamic CMO (contract manufacturing organisation) for production of biologics are:- Leading and coordinating a team of QC (quality control) scientists responsible for verification, qualification and validation of analytical methods for biopharmaceuticals (clinical phase I-III and commercial).- Responsible for meeting project goals, team KPIs and managing resources.- Coordinating and overseeing transfer and qualification / validation activities across network and with external customers.- Managing deviations and compliance activities (alignment of internal procedures with global standards and regulatory requirements, health authority and customer audits). - Implementation of improvements and optimisations within QC (Biochemical and Microbiology laboratory).- Overseeing and auditing external contract laboratories for safety testing (mycoplasma and viral testing). - As QC scientist manager I am in constant communication with QC (technicians and lab supervisors), Project management team, Operations, Site leadership team and external contractors and customers. Show less

  • QC Manager (Head of QC)

    Mar 2019 - Mar 2020

  • QC scientist Manager (Head of QC scientists)

    Feb 2018 - Jun 2019
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  Novartis

  Apr 2020 - Aug 2023

  - Leading a team globally responsible for qualification and quality oversite of API suppliers and materialssupplied to various Novartis sites. Team is responsible for routine quality monitoring (audits, Quality RA, QAA), making sure that processes are compliant with regulatory expectations, escalations and new API qualifications.- People leadership: onboarding and training/ coaching people, motivating them and taking care for their development. Strategic planning of resources for routine work, projects and planning work and priorities ahead.- Project management: I led many improvement project or participated in projects like: harmonization of ESO processes across the network, new QAA template, global temperature monitoring for API, automatic BOT for distribution of approved regulatory dossier to external suppliers, etc.- Actively involved in Sandoz-Novartis split and setting up strategy for future API processes within Sandoz.- Responsible for meeting project goals, team KPIs and managing resources (FTEs and budget) and timeliness.- Involved in serious quality deviations and escalations or other issues related to Quality.- Aligning activities with organizational needs, defining yearly department goals, development plans andoptimization projects.- Frequent interactions with suppliers, Novartis sites and global functions. Show less - Responsible to support quality oversight for purchased API’s, starting materials and chemical intermediates supplied into Novartis NTO sites worldwide.- Participates and supports changes of supplier qualification and certification status for external Suppliers.- Manages major and critical quality issues (reclamations, stability issues, deviations, etc.).- Performs risk assessments, including collecting relevant data from NTO sites and other stakeholders, and approval of site specific risk assessments where required.- Responsible for preparing Quality Agreements for specific External Suppliers.- Quality oversight and follow up of audit observations.- Participates in High Risk Supplier evaluation process, and assures that actions originating from this process are executed and properly documented. Pro-actively communicates supplier status changes (incl. high risk suppliers) with NTO sites.- Provide direction and support to third parties and ensure that they and are motivated to carry out their duties to ensure that the materials produced meet the Novartis quality, efficacy and safety requirements. Show less

  • ESO QA Lead

    Feb 2021 - Aug 2023

  • Senior QA manager ESO Chemicals & Anti-infectives

    Apr 2020 - Feb 2021
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  Lek, a Sandoz company

  Aug 2023 - now

  Head Development QA Biosimilar Alliance projects

  My maine responsibilities: - Establishing a new global team in standalone Sandoz organisation for QA oversite of Biosimilar alliance projects.- coaching and training new team members- developing new processes that will enable us to work successfully with our CDMOs- being accountable for meeting team goals and project goalsMain team resposibilities are:- Quality oversite of development projects outsourced to our CDMO partners- CDMO qualification activities including planing of audits and audit follow up and establishing QAAs with external CDMOs and service providers Show less