ALEX UDOVČ
Mirna Peč
Summary
I am a seasoned professional with over 14 years of experience in the pharmaceutical industry, specializing in supply chain and manufacturing. My expertise lies in connecting market needs with manufacturing capabilities and financial aspects. As a proven leader, I have successfully coordinated development and life cycle projects, ensuring they are completed on time and within budget by effectively managing priorities and solving problems. I am a team player and a skilled communicator, known for being responsible, proactive, and having a strong sense of urgency. My leadership capabilities are demonstrated through my ability to inspire and guide teams towards achieving constant improvements and challenging the status quo. I am particularly inquisitive in the fields of pharma business, information technology, and people management, always striving to enhance my knowledge and skills.
Overview
15
15
years of professional experience
Work History
Supply Point Evaluation Lead
Novartis
09.2024 - Current
- Finalized 25 business cases with all of them being endorsed for further implementation (including multibillion dollar brands).
- Leading global cross functional team of subject matter experts during the business case preparation stage.
- Supporting TechOps strategic objectives with on time proposals for new/additional manufacturing sites.
- Managing stakeholders on the platform level to assure timely endorsements of prepared business cases
- Assured comprehensive handover to program and project teams, for further project implementation
- Acting as a SPOC for Small molecules platform
- Running supply point management office including OpEx initiatives, IT management and user training’s
Supply Chain Life Cycle Manager
Novartis
04.2021 - 09.2023
- Managing variety of life cycle events (launches, transfers, process optimizations) for 8 innovative medicine brands, 2 biosimilar brands.
- Leading multicultural cross site teams. Facilitation of project meetings and preparation of project plans
- Establishing clear project governance to ensure better transparency and reporting on project and program level.
- Leading standardization workstream, for optimization and standardization of transfer process across 7 different manufacturing sites
Project Manager for New Product
Krka d. d., Novo mesto
06.2017 - 04.2021
- Led the evaluation teams which prepared more than 8 business cases for new drug development out of which 6 ware confirmed for implementation.
- As a project lead secured "first generic on the market" spot for 3 products.
- Assure all product feasibility studies are supported with the relevant data and data analytics using data bases such as Iqvia, Globaldata, Citeline and various open-source clinical research data bases such as Iqwig.
- Providing all necessary prerequisites for planning of R&D activities such as product specification based on market expectation, launch plans, volumes.
- Evaluation and due diligence of potential CM and CD partners.
- Tracking the economic and market situation to make better decisions.
- Coordinating the process of implementation of new API and excipient sources and process optimizations to ensure business continuity and cost efficiency
- Preparation of consolidated reports reflecting project deliverables, timeline adherence, costs and risk&ops for management board.
- Leading the PMO digitalization initiative, to design the collaboration IT interface for fast exchange of relevant project information and on-line reporting system.
- Monitored progress against established goals, adjusting schedules and resources as needed to keep projects on track.
API Particle Design Team Lead
Krka d. d., Novo mesto
07.2015 - 06.2017
- Leading the team of 7 associates.
- Assigned resources in line with portfolio strategy Providing training and ensuring employees growth.
- Prepared experimental plans for lab scale experiments such as crystallization, isolation, drying, milling and sieving.
- Prepared procedures for scale-up from lab to pilot and from pilot to industrial scale.
- In charge of the preparation of process documentation such as MBR, Cleaning procedures, validation protocols, validation reports.
- Ensured that all processes in the pilot and industrial scale was going on according to ICH Q7 guidelines.
- Responsible for identifying deviations in processes, on an industrial scale, that ensure all activities are cGMP compliant.
- Involved in implementation of Corrective Action and Preventive Actions (CAPAs).
- Keenly prepared guidelines for operating in Ex area.
Chemical Technician
Krka d. d., Novo mesto
09.2010 - 07.2015
- Performed lab-scale experiments aiming to provide the best possible morphological characteristics that meet the needs of the certain formulation process.
- Prepared (final operations - isolation, drying, milling) API batches for clinical and bio-equivalence trials.
- Conducted chemical and physical laboratory tests for analyzing solids, liquids and gaseous materials.
- Managed laboratory supplies and inventory. Prepared technical reports on experimental results.
Education
Master of Arts - Business and Organization
The University of Ljubljana - Faculty of Economics
Ljubljana06.2025
Bachelor of Science - Chemical Technology
The University of Ljubljana - Faculty of Chemistry And Chemical Technology
Ljubljana04.2015
High School Diploma -
Grm Novo Mesto - Biotechnical Gymnasium
Novo Mesto05.2008
Skills
- Particle design & size analysis
- Manufacturing
- Risk management
- Microsoft Office
- Pharmaceutical technology
- Statistics
- Project management
- Data analytics basics
- Accounting basics
- Fast Learner
- Judgement and Decision Making
- Leadership Skills
- Strategic thinking
- Communicative
- Business Planning
- Due diligence
- Problem-solving Abilities
- Problem-solving
- Teamwork and collaboration
LANGUAGES
Slovenian
English
German
Serbo-croatian
Timeline
Supply Point Evaluation Lead
Novartis
09.2024 - Current
Supply Chain Life Cycle Manager
Novartis
04.2021 - 09.2023
Project Manager for New Product
Krka d. d., Novo mesto
06.2017 - 04.2021
API Particle Design Team Lead
Krka d. d., Novo mesto
07.2015 - 06.2017
Chemical Technician
Krka d. d., Novo mesto
09.2010 - 07.2015
Master of Arts - Business and Organization
The University of Ljubljana - Faculty of Economics
Bachelor of Science - Chemical Technology
The University of Ljubljana - Faculty of Chemistry And Chemical Technology
High School Diploma -
Grm Novo Mesto - Biotechnical Gymnasium
Hobbies and Interests
Mountain biking & Basketball, Leading different construction projects for friends and family., Leading projects and acting in the municipal cultural association
LINK'S
LinkedIn
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