Работал в 3 компаниях   6 лет 5 месяцев

Фармацевтика

Co-founder, CEO

ED Pharma (Bulgaria)

Фармацевтика

3 года 10 месяцев

07.2022 - по настоящее время

Boutique advisory focused on EU GMP pharma and chemical manufacturing. Working directly with owners and plant leadership teams to stabilise, optimise and prepare sites for growth, inspections or transactions.

Key focus areas:

- Pharmaceutical technology and engineering: development, optimisation and scale-up of manufacturing processes.

- Identifying and removing production bottlenecks, improving throughput and OEE on existing assets.

- Enhancing Quality Management Systems (QMS) in line with EU GMP expectations.

- Selection, assessment and implementation of production and auxiliary equipment for new and existing lines.

- Hands-on support to mid-size EU GMP sites in CEE/Balkans that need practical, plant-level expertise rather than generic consulting.

Managing Director (COO), Qualified Person (QP)

Interchemie werken De Adelaar B.V. (Estonia)

Фармацевтика

1 год 2 месяца

08.2024 - 09.2025

- Led the recovery of suspended sterile manufacturing by forming a crisis team and agreeing on weekly progress reporting with the regulator (Ravimiamet). Restored the manufacturing license within ~2.5 months, preventing ~€1M in monthly downtime losses, retaining key customers, and avoiding the need to relocate production to the Netherlands.

- Restructured the organization by strengthening the leadership team (including a Technical Manager, Head of HR, QP and other critical roles) and establishing a dedicated QP/QA function. This ensured stable operations without constant hands-on “manual control” and increased investor confidence in a €50–60M turnover business with a workforce of ~180 employees.

- Increased sterile output by 25% (from ~1.2M to 1.5M+ units per month) through improved planning and bottleneck removal, generating an additional €200–250K in monthly revenue (~€2.4–3.0M annually) without a proportional increase in fixed costs - by improving utilization of existing equipment and capacity rather than adding CAPEX.

- Restored licenses for aerosol and intramammary products, updating the MIA, expanding the active product portfolio, improving diversification and investment attractiveness.

- Led preparation for and the successful completion of a critical inspection by the national regulator (Ravimiamet) within an EU GMP framework, building a transparent regulator communication process and materially reducing regulatory risk under high-pressure conditions.

CEO / COO

New Garden Pharma DOOEL Skopje (North Macedonia)

Фармацевтика

4 года 7 месяцев

12.2019 - 06.2024

- Led a 2,400 m2 greenfield facility build-out to EU GMP/GACP standards for medical cannabis products with a €7M CAPEX budget. Delivered €1.7M (~20%) savings through design/scope optimisation and contractor selection. Ramped operations with a 15–20-person team and materially improved the project’s investment efficiency and payback profile.

- Built and EU GMP-certified a full manufacturing chain (flowers, extracts, API/FDF), including a QC laboratory (AMV/QCM) and CTD dossier preparation. Export model to Australia, UK and Germany.

- Managed €850K+ OPEX. Ensured day-to-day cost control and a stable operating run-rate during ramp-up and transition to routine operations.

- Delivered commercial entry into export markets by aligning customer requirements and adapting products/documentation. Established sales in both spot and off-take models. Occasionally accepted minimal initial margins to enter priority markets.

Ключевая информация

- Crisis & Turnaround Leadership under Regulatory Pressure.

- High-stakes Decision-Making (QP accountability, business trade-offs).

- Stakeholder Management with Regulators, Investors & Key Customers.

- Building Strong Leadership Teams & Operating Governance.

- Execution Discipline & Accountability Culture.

- EU GMP Regulatory Strategy & Inspection Management.

- P&L / OPEX / CAPEX Governance (cost discipline, investment prioritization).

- Margin & COGS Improvement on Existing Assets.

- GMP Project Delivery (Greenfield/Brownfield): On-time, On-budget, Audit-ready.

- QP: Final Batch Disposition (Release/Reject) & License Risk Control.

  • Комунікабельність
  • Microsoft Access
  • Excel
  • Word
  • Учился в 1 заведении

    Національний університет харчових технологій

    Біотехнологія

    2005

    Владеет языками

    Английский

    свободно

    Может проходить собеседование на этом языке

    Может проходить собеседование на этом языке

    Досвід в ЄС

    Болгарский

    выше среднего

    Македонский

    свободно

    Украинский

    родной

    Может проходить собеседование на этом языке

    Может проходить собеседование на этом языке

    Україна!

    Курсы, тренинги, сертификаты

    PRINCE2® 7 Foundation and Practitioner — Nordic Koolitus OU, Tallinn, Estonia

    2025

    LEAN methods (implementation and use) — Tallinn University of Technology, Estonia

    2025

    Qualified Person (QP) Course — Intellect plus s.r.o., Bratislava, Slovakia

    2025

    Sterilizing Filtration Validation — Intellect plus s.r.o., Bratislava, Slovakia

    2025

    Sterilizing Filtration: Risk Assessment & PUPSIT — Intellect plus s.r.o., Bratislava, Slovakia

    2025

    Product Quality Reviews (PQR) — Standards Technologies Development (STD), Kyiv, Ukraine

    2025

    Handling of Inappropriate Pharmaceutical Products — STD, Kyiv, Ukraine

    2025

    EU GMP: Introduction & Annex 1 — Zamann Pharma Support GmbH, Germany

    2024

    Дополнительная информация

    Водійське посвідчення

    Category B from 2009 (17+ years)

    Громадська діяльність

    Участь у роботі української громади в Македонії

    Комп'ютерні навички

    MS Office, MS Project (+Server), AutoCAD, REVIT (MEP, Structure)

    Свій розділ

    CEO/COO building and turning around EU GMP pharma and chemical plants in European markets with high regulatory pressure, price controls and expensive energy, where manufacturing margins are heavily constrained.

    For 18+ years I’ve been working across CEE and Europe as a CEO/COO, Qualified Person (QP) and former Production Director – usually stepping in when a plant is under regulatory pressure, margins are squeezed and owners are not sure whether to close, sell or invest.

    What I’m good at:

    - Protecting licences and fixing critical GMP issues,

    - Unlocking +20–30% output and 5–10% cost improvements on existing assets,

    - Delivering greenfield/brownfield projects under budget and ready for EU GMP audits,

    - Building management teams so plants can run without daily control from the owner.

    When it makes business sense, I also look for energy and resource efficiency levers – not as “greenwashing”, but as a way to protect margins in high energy-cost environments.

    Open to conversations with owners, family offices, PE funds and corporate groups about underperforming or “at risk” manufacturing assets.

    Oleksandr

    Chief Executive Officer, COO, Production director, Technical director

    Киев

    Готов переехать: Львов, Винница, Ивано-Франковск

    5 000 $

    45 лет

    Активно ищет работу

    полная занятость

    Последняя активность 1 день назад