Kyra Cole
Founder
Experience
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.
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.
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.
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.
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.
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.
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.
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.
Industries Experience
See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.
Experienced in Education (7 years), Automotive (3.5 years), Aerospace and Defense (3.5 years), Healthcare (3.5 years), Manufacturing (3.5 years), and Pharmaceutical (3 years).
Business Areas Experience
The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.
Experienced in Research and Development (11 years), Project Management (9 years), Product Development (8 years), Information Technology (5.5 years), and Quality Assurance (4 years).
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
Education
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
Profile
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