Konstantin Brianv

Bis 2025, Production Manager, R-Pharm Germany GmbH
Ulm, Deutschland

Fähigkeiten und Kenntnisse

Project Management
Biotechnology
Operational Excellence
Biologics
Good Manufacturing Practice (GMP)
Pharmaceutical Manufacturing
Downstream Processing
Upstream Processing
FDA GMP
EMA
Manufacturing Scale-up
Technology Transfer
Production Management
Operations Management
Bioprocess Development
Validation (Drug Manufacture)
Process Qualification
Process Monitoring
Single Use Technology
Root Cause Analysis
Process Automation
Corrective and Preventive Action (CAPA)
Chromatography
Tangential Flow Filtration
Aseptic Processing
Supplier Management
Lyophilisation
Supplier Quality Management
Vendor Management
Supplier Negotiation
Quality Management
Quality Auditing
Internal Audits
External Audits
Standard Operating Procedure (SOP)
Technical Documentation
Monoclonal Antibodies
Team work
Communication skills
Cross functional Team Leadership
Mentoring

Werdegang

Berufserfahrung von Konstantin Brianv

  • 5 Jahre, Sep. 2020 - Aug. 2025

    Production Manager

    R-Pharm Germany GmbH

    • Led facility redesign and 2000L bioreactor installation, incl. equipment selection and supplier negotiations. • Eliminated sterilization gap, reducing lead times by 30-56 weeks and saving €60K annually. • Achieved GMP readiness within 1.7 yrs. • Passed 2 GMP inspections on first attempt; hosted 20+ partner visits. • Planned R&D center in Azerbaijan, incl. equipment relocation, customs clearance, and supply chain risks. Repurposed idle tablet block into R&D hub, cutting CAPEX 4× and timelines by 6 months.

  • 7 Monate, Dez. 2019 - Juni 2020

    Senior Quality Control Manager

    Glomako LLC

    • Scaled disinfectant production from ~2.5 t/week to ~25 t/week within three weeks during COVID demand by separating production and filling flows, launching a second filling line, implementing mixing adjustments, and hiring additional staff. • Stabilized raw material supply (isopropanol ~20 t/week) through incoming QC and managing product returns to ensure quality. • Led ISO recertification as Head of QC by preparing documentation, coordinating with the auditor, and successfully extending certifications.

  • 7 Jahre und 2 Monate, Nov. 2012 - Dez. 2019

    Production Manager

    BIOCAD

    Promoted from Biotechnologist to Process Engineer and then Production Manager • Key technical stakeholder in establishing full-cycle biotech manufacturing from pilot to full-scale GMP production. • Scaled mAb processes (cell culture, cultivation, chromatography, TFF, viral clearance) from pilot to production • Developed overall layout design(22,000 m²) and process flows managed Fill & Finish (aseptic filling, lyophilization) • Provided process input for equipment specifications and commissioning activities

  • 2 Jahre und 2 Monate, Okt. 2010 - Nov. 2012

    Senior Chemist, R&D

    Samson-Med LLC

Ausbildung von Konstantin Brianv

  • 4 Jahre und 10 Monate, Sep. 2004 - Juni 2009

    Biotechnology Engineering

    St. Petersburg State Technological Institute

    GPA: 4.7/5

Sprachen

  • Russisch

    Muttersprache

  • Englisch

    Fließend

  • Deutsch

    Grundlagen

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