Kyra Cole

Founder

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Niedernhausen, Germany

Experience

Feb 2025 - Present
1 year
Niedernhausen, Germany

Founder

C/C++ Consultancy for Pharma and Clinical Software Development and Digitalization Support

  • Architected an open clinical framework for digitalization in pharma and clinical software development.
  • Developed a minimum viable product (MVP) for the framework, applying agile methodologies and rapid prototyping best practices while ensuring GxP validation and HIPAA compliance.
May 2021 - Apr 2023
2 years
Mainz, Germany

Global Digitalization Project Manager

BioNTech SE

  • Defined and deployed a core MES (PAS-X, Körber Pharma GmbH) software system across multiple BioNTech sites, standardizing digital manufacturing processes and enhancing operational efficiency.
  • Designed validation and configuration management concepts to ensure system integrity and regulatory compliance.
  • Served as the primary liaison between BioNTech and Körber Pharma GmbH, facilitating effective communication and project alignment.
  • Managed a digitalization program for the Idar-Oberstein site, overseeing 15 projects and acting as subject matter expert for chain of identity and custody processes.
  • Directed Master Batch Record (MBR) development for individualized cancer treatments and implemented GxP validation across all projects, ensuring quality and compliance.
Aug 2016 - Mar 2020
3 years 8 months
Lindau, Germany

EBA Function Delivery Owner

Megapart GmbH and Continental, A.D.C. GmbH

  • Defined and developed Emergency Brake Assist functions for multiple sensors and OEMs, ensuring timely delivery in an agile environment.
  • Coordinated and validated functional delivery, managing end-to-end project execution and ensuring adherence to project timelines.
  • Negotiated with customers, including Asian and premium German OEMs, to resolve issues and align project goals.
  • Led software development, change management, and requirements management to support project objectives and deliver high-quality solutions.
May 2012 - Aug 2015
3 years 4 months
Hamburg, Germany

Project Manager R&D

Tagueri Group GmbH

  • Led development of innovative research techniques for European Commission-funded projects, focusing on process monitoring and error reduction in medical and aviation manufacturing.
  • Managed software, product, and project development for the research department, utilizing GPU acceleration for simulations and advanced data analysis.
  • Negotiated commercial contracts and managed customer relationships for the R&D group, ensuring project success and client satisfaction.
  • Coordinated team resources to maximize efficiency and project outcomes.
  • Developed heat conductivity simulations, evolutionary algorithms for intelligent stock picking, and high-performance fitting algorithms for 3D data analysis.
  • Integrated advanced sensors into manufacturing processes to enhance data collection and process optimization.
Feb 2012 - Feb 2013
1 year 1 month
Hamburg, Germany

System Engineer V&V Processes

Airbus GmbH

  • Validated and verified ALNA (Infotainment and Wireless Internet Access) systems on Airbus aircraft, ensuring compliance with industry standards and project requirements.
Jan 2006 - Dec 2012
7 years
Frankfurt, Germany

Physics Laboratory

University of Frankfurt

  • Built a femtosecond laser laboratory in a clean room, maintaining and training safety protocols for all students and staff.
  • Participated in research experiments and performed analysis of experimental data.
Jun 2002 - Dec 2003
1 year 7 months
Berkeley, United States

Graduate Student

Lawrence Berkeley National Laboratory

  • Conducted advanced experiments and research projects using various light sources, including spatial and temporal alignment of laser beams with synchrotron radiation.
  • Collaborated with peers on team projects and presented research findings to faculty, demonstrating strong communication and teamwork skills.
Bad Vilbel, Germany

Senior Consultant

Frontwell Solutions GmbH

  • Led requirements engineering for a Manufacturing Execution System (MES) project in a pharmaceutical environment, ensuring alignment with business and regulatory needs.
  • Developed and implemented a data analytics dashboard to deliver actionable insights from manufacturing and laboratory data, improving decision-making efficiency.
  • Managed MES system validation for a pharmaceutical client, ensuring full regulatory compliance and successful project delivery.

Summary

Results-driven project owner and physicist with over 8 years of experience in atomic, molecular, and optical physics, specializing in data analytics, digital transformation, and project management. Proven track record in leading cross-functional teams to deliver data-driven solutions in highly regulated sectors such as pharmaceuticals and manufacturing. Expertise in requirements engineering, advanced data analysis, and process optimization.

Skills

Programming Languages

  • C/c++
  • Cuda
  • Labview
  • Python
  • Sql

Environments

  • Linux
  • Unix
  • Windows

Methods

  • Scrum
  • Project Management
  • Six Sigma
  • Doe+

Hardware

  • Clean Room Fs-pulsed Lasers
  • Coltrims
  • Accelerators
  • Vacuum Chambers
  • Mass And Electron Spectrometer

Software

  • Microsoft Office
  • Mathematica
  • Doors
  • Ptc
  • Ms Project

Systems

  • Mes (Pas-x)
  • Erp (Sap)
  • Nicelabel
  • Nymi
  • Lims

Languages

German
Advanced
English
Advanced

Education

Oct 1998 - Jun 2006

Johann Wolfgang Goethe University

Diplom Physicist (Master of Science in Physics equivalent) · Physics · Frankfurt, Germany

Certifications & licenses

Applied Data Science Program: Leveraging AI for Effective Decision-Making

MIT Professional Education

Laser Safety Officer Certification

SA Certified SAFe® 5 Agilist

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