Experience

• 

  Lek pharmaceuticals d.d., a sandoz company

  Oct 2001 - May 2014

  • Managing a group of researchers and analysts, encouraging their personal development and following up on action plans, setting high standards of performance• Working with GMP quality systems elements, such as validations, investigations and corrective actions• Building and maintaining a collaborative working relationship with internal and external customers• Intensive cooperation on international projects. Preparing documents (protocols and reports) and coordinating activities for Analytical method transfers.• Cooperating with Business Development & Licensing (BD&L) projects for Emerging Markets and establishing processes.• Revising and maintaining Standard Operating Procedures in accordance with current regulatory guidelines and company´s quality standards.• Participating in compliance inspections and internal audits In addition, working as a researcher and having the same responsibilities as described in the previous position. Show less Oct. 2009 – Oct. 2011; Researcher in Regulatory Analytics Department• Preparing, reviewing, and approving documents such as specifications, analytical methods, stability protocols, stability reports and certificates of analysis • Investigating OOS/OOT/OOE, deviations to determine root cause and defining corrective/preventative actions• Supporting Stability studies by preparing Stability Protocols in accordance with ICH guidelines and other applicable standards. Conducting force degradation studies, trending and reporting stability data • Preparing Protocols and Reports of comparative dissolution profiles and biowaivers by following relevant guidelines• Preparing documents for submissions to Health Authorities worldwide and responding to deficiency letters. Responsible for issuing and maintaining Change control formsJun. 2008 – Sept. 2009; Researcher in Analytical Development Department• Analytical support in early development of new generic formulations, comparing impurity profiles of drug substance from different manufacturers and checking compliance with pharmacopoeia monographs if applicable • Developing a variety of analytical methods for drug substances and newly developed drug products, setting specifications, preparing analytical documentation for dossier and responding to deficiency letters. Performing trouble-shooting on analytical methods Show less

  • Group Head in Regulatory Analytics

    Nov 2011 - May 2014

  • Researcher Drug development

    Jun 2008 - Oct 2011

  • Researcher Drug Discovery

    Jan 2004 - May 2008

  • Analyst

    Oct 2001 - Dec 2003
• 

  Teva pharmaceuticals

  May 2014 - Mar 2017

  Head analytical development

  • Professional and disciplinary management of the team • Consciously creating a workplace culture that emphasizes quality, continuous improvement, key employee retention and development, and high performance• Accomplishing staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching and counseling employees • Planning, evaluating, and improving the work systems, procedures, and policies to enhance speed, quality, efficiency, and output of people and other resources• Establishing and maintaining relevant controls and feedback systems to monitor the operation of the department• Management of the overall operational, budgetary, and financial responsibilities and activities of the department• Incorporating the latest trends in analytical method development, also analytical QbD. Show less

• 

  Sandoz

  Apr 2017 - Mar 2020

  R&d project manager

  - responsible for scientifically sound and timely development of new generic drug products, from idea to launch in key markets,- performing efficient project management, preparing strategies, managing project scope, schedule and costs, focusing on risk management, quality and stakeholder engagement,- coordinating cross-functional and international teams,- responsible for personal development of the project team members,- managing in-house projects, license projects and co-developments with external partners. Show less

• 

  Thermosome

  Apr 2020 - May 2021

  Senior cmc project manager

  - responsible for the development and manufacture of a novel, thermo-sensitive nanocarrier for local high-concentrated delivery of active pharmaceutical ingredients (APIs) for the treatment of local tumors,- daily coordination of multifunctional team and external partners (CMOs, CROs, Regulatory and other consultants,...),- supporting clinical team at planning the clinical study,- responsible for the project budget and timelines.

• 

  Immunic therapeutics

  Jun 2021 - now

  - leading a project management team,- implementing general processes and guidelines for successful product development strategy deployment on every project of the company portfolio,- responsible for all drug substance and drug product activities from pre-clinical development through clinical supplies for phase III clinical studies,- identifying, selecting and overseeing activities at CMOs related to development, manufacture and supply of API and drug product for clinical programs.

  • Global Head of Pharmaceutical Development

    Jan 2024 - now

  • Head of CMC Development and Operations

    Jun 2021 - Jan 2024