Oleksii Ivanov Email & Phone Number

Karlsruhe, Baden-Württemberg, Germany

Karlsruhe, Baden-Württemberg, Germany

• Responsibilities:
• Leading functional execution of complex software delivery project for German TOP Pharma customer.
• Requirement collection, process analysis, recipe design, recipe validation, Go-Live, hypercare support.
• Responsibility for meeting project schedule, design budgets, customer satisfaction and compliance targets.
• Building partnerships at a functional requirement level of customer counterparts.
• Consulting customer regarding process- and project optimization.

Walldorf, Germany

• Responsibilities:
• Collaboration work on complex international device and reagent sales projects, including lead generation and qualification, preparation of offers, strategic planning and handling of customer communication and.
• Creation of strategic customer and distributor communication on product, price, and portfolio information.
• Creation and processing of rental contracts, leasing or hire purchase for end customers.
• Editing the CRM database to update customer data.
• Elaboration and implementation of the agenda of distributor meetings and customer trainings.

Kiev, Ukraine

• Responsibilities:
• Monitoring of changes and trends in regulatory landscape in the assigned markets.
• Leading the implementation of approved registration plan in collaboration with foreign consulting partners.
• Responsibility for on-time registration, re-registration, dossier changes in the countries of sale.
• Checking the registration dossier for the drug, its submission to authorized regulatory bodies and coordination of its final registration.
• Customs clearance of samples and standards for analytical control of a drug in the country of registration

Kiev, Ukraine

• Responsibilities:
• Management of optimization activities in compliance with regulatory limitations.
• Responsibility for consolidation and development of optimization plan for QC Unit.
• Monitoring, coordination, and implementation of optimized quality control activities directly on manufacturing facilities
• Responsibility for development and implementation of statistical control methods and risk assessment for reduction of volume and quantity of in-process control as well as control of incoming materials.
• Created regulatory justification background for optimization of quality control for regulatory authorities.

Kiev, Ukraine

• Responsibilities:
• Purification of human recombinant proteins.
• Preparative chromatography.
• Gel electrophoresis.
• Spectrophotometric detection of protein concentration.

Master'S Degree, Biotechnology, Gpa 5.0 On 5-Point Scale. (5 - Excellent. 4 - Good. 3 - Satisfactory.)

Activities and Societies: Research at the Institute of Microbiology and Virology of National Academy of Sciences of UkrainePlanning.

Doctor Of Philosophy (Phd), Philosophy Of Health, Sociobiotechnologies, Medicalization.

Thesis: "Health in the discourse of human social being"

Education record