Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
BusinessAnalyst
MONIKA STUCZEN

MONIKA STUCZEN

Chippenham,WIL

Summary

Experienced Senior Research Manager with over 10 years of expertise in senior managerial roles and R&D within the industry, NHS, and academic settings. Doctoral degree in Medical Microbiology. Skilled in leading multiple cross-disciplinary teams and projects. Creative and results-oriented problem solver and innovator with a proven track record of successful innovations and product development. Extensive knowledge of medical device, GMP, and GCP standards and regulations.

Overview

17
17
years of professional experience
1
1
Certification

Work History

Senior Research Manager

Dyson Technology Ltd
08.2021 - Current
  • Leading and coaching global Microbiology team
  • Overseeing multiple teams ensuring the successful delivery of complex and high-impact projects across all categories including New Ventures
  • Providing expertise in the field of microbiology, medical devices, and regulatory requirements influencing technical directions across projects
  • Driving hygiene innovations to improve new and existing products
  • Introducing new "Proof of Concept" ideas and presenting to stakeholders for development approval
  • Supporting with knowledge and expertise other teams across Dyson (Claims, Legal and Commercial Team)
  • Promoting Dyson research on the global level

QC Microbiology Lab Manager

R&D, Medical Wire & Equipment Ltd
12.2013 - 07.2021
  • Responsible for an effective and efficient day-to-day leadership of the R&D and Quality Control laboratory
  • Established and maintained quality control standards, contributing to accurate test results and reliable data collection
  • Proven record of new products design and implementation (Class IIa and IIb medical devices)
  • Set and oversaw quality assurance guidelines for laboratory work and GMP procedures at the manufacturing site
  • Set up product trials and validations (internal and external)
  • Developed collaboration with research institutions (Universities/research centres)
  • Supported other teams to drive their success (Sales, Quality Assurance)

Academic Support Tutor

Manchester Metropolitan Univeristy
09.2008 - 09.2013

•Assisted students in small groups or one-on-one sessions to enhance education and provide support in achieving learning objectives set by University

• Teaching Units- General and Medical Microbiology, Genetics, DNA and Human Disease, Molecular Techniques, Haematology, and Immunology

  • Guiding undergraduate students in scientific writing,

referencing, preparing presentations, designing posters and scientific reports

  • Promoted a positive learning environment by addressing

individual student needs and offering constructive feedback

Research Scientist

Manchester Metropolitan University
08.2007 - 09.2011

August 2007 – January 2010 - Lead Microbiologist - 2-year Clinical Trial comparing the effectiveness of 3 different treatments of diabetic ulcers (Larval therapy, Biogun and Silver dressings).

• Responsible for collecting samples, testing, and analysing data of clinical trial participants

• Presenting trial results to various stakeholdersat conferences and annual meetings

September 2007 – October 2008 - Lead Microbiologist - 1 year international clinical trial - Development of a Diagnostic Aid for Bacterial Infection in Wounds.

• Contributed to developing an innovative medical device (an electronic nose based on a Hybrid Gas Sensor System) to monitor wounds for early detection of infection.

August 2007 – September 2011 -

• Successfully led numerous research projects in collaboration with Industry, comparing antimicrobial performance of different wound dressings, products validation, and development of swab transport systems according to CLSI standards.

Education

Ph.D. - Medical Microbiology

Manchester Metropolitan University
UK
07.2013

Master of Science - Biomedical Sciences

Medical University of Bialystok
Poland
06.2005

Bachelor of Science - Biomedical Sciences

Medical University of Bialystok
Poland
06.2003

Skills

  • Strong leadership and team building 10 years
  • Project Management
  • Medical Device Regulatory Expertise
  • ISO 13485, ISO 14971, ISO 11737, FDA, MDR, MDSAP
  • Beauty products regulatory experience
  • GMP, GCP and CSLI standards
  • Clinical Trials
  • In-vitro Assay Development
  • QMS and audit experience
  • Problem Solver/Innovator
  • Experience in leading cross - disciplinary teams
  • Experience in designing Bio Safety Level 2 Microbiology Labs

Certification

University of Oxford - Project Management (2023)


Level 3 Award in Emergency First Aid at Work (2024)


Harvard Global Health Institute Lessons from Ebola: Preventing Next Pandemic - Certificate issued May 2020


Fast Track Cell Culture Qualsafe



Languages

  • English – Proficient
  • Polish - Native
  • Portuguese - Basic

Timeline

Senior Research Manager

Dyson Technology Ltd
08.2021 - Current

QC Microbiology Lab Manager

R&D, Medical Wire & Equipment Ltd
12.2013 - 07.2021

Academic Support Tutor

Manchester Metropolitan Univeristy
09.2008 - 09.2013

Research Scientist

Manchester Metropolitan University
08.2007 - 09.2011

Ph.D. - Medical Microbiology

Manchester Metropolitan University

Master of Science - Biomedical Sciences

Medical University of Bialystok

Bachelor of Science - Biomedical Sciences

Medical University of Bialystok

University of Oxford - Project Management (2023)


Level 3 Award in Emergency First Aid at Work (2024)


Harvard Global Health Institute Lessons from Ebola: Preventing Next Pandemic - Certificate issued May 2020


Fast Track Cell Culture Qualsafe



MONIKA STUCZEN