Andriy Stelmakh Email & Phone Number

Vienna, Austria

- Process and technology expert for immunoglobulin and other plasma-derived porducts- Implementation of new products and manufacturing porcesses- Participation in manufcaturing of technical, pre-clinical and clinical batches- Process automation and data analysis- Risk assessments, Change control, Support of equipment qualification activities, Process Validation- Evaluation of Critical Quality Attributes and Critical Process Parameters, development of control strategies- Improvement of qulity, process robustness and efficiency

Vienna, Austria

- Planning, coordination and execution of product- and process transfers- Root Cause analysis as an expert for process technology- Validations of manufacturing processes for solid dosage forms- Evaluation and optimization of manufacturing processes using Six Sigma principles- Selection of alternative suppliers of raw materials (APIs and excipients) while assuring deviation-free processing, meeting in-process controls, limits of specification and other performance related characteristics of a drug product (e. g. desired in vitro dissolution profiles for modified release dosage forms)- Change Control management- Preparation of material specifications, protocols and manufacturing instructions- Evaluation and selection of new technologies

Vienna, Austria

Development of a novel small-molecule drug of a DHODH-inhibitor class formulated as intravitreal injection and eye drops to treat ophthalmic inflammatory disorders.Planned and supervised the following external CMC activities:- API Synthesis according to cGMP- Analytical development, validation of methods- Formulation development (injectable formulation, eye-drops, sustained-release formulations)- Stability studies with API and Drug ProductsManaged all CMC aspects from planning and vendor selection to providing IMPs supplies for clinical trials while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelinesPrepared CMC parts of regulatory filings (e.g. IMPD, SA) while keeping to ambitious timelines and allowing the start of clinical trials without a delay due to CMC related deficiencies

Kyiv, Ukraine

Detailed planning and management of pharmaceutical development of generic drugs (solid forms, injectables, plant extracts).Simultaneous management of several projects at different stages in pharmaceutical development

Ebenfurth, Austria

- Operational planning of production of plant protection products- Supervision, campaign documentation, troubleshooting- Safety trainings of the staff, preparation of SOPs- Coordination with purchasing, QC, R&D, logistics

Linz, Austria

- Chemical process research and development; Process transfer- Hands on experience with GC, HPLC, NMR, IR, DC, MS, DSC, RC1- API stability testing, thermal process safety- Route scouting; literature searches; cost calculations- Leading of laboratory technicians and Process documentation

Master Of Legal And Business Aspects In Technics (Mlbt), Economics, Law

http://www.jku.at/content/e262/e242/e2380/e2403/

Dr. Rer Nat., Organische Chemie

Activities and Societies: Synthesechemie, Totalsynthese, Naturstoffsynthese Hexacyclinsäure (Hexacyclinic acid, FR182877), Tandem Michael.

Ms, Organic Chemistry, Distinction Diploma

Activities and Societies: Heterocyclic Chemistry

Bs, Chemistry, Distinction Diploma

Mathematics