Recommended expert

Dirk Kaiser

Freelancer, Owner

Dirk Kaiser
Erbach, Germany

Experience

Jan 2010 - Present
16 years 1 month
Erbach im Odenwald, Germany

Freelancer, Owner

SIGNYPHARM CONSULTING

  • Worked in different positions offering comprehensive solutions across the entire pharmaceutical product development process
  • Supported teams in Europe and India from early drug substance (DS) and drug product (DP) development to regulatory compliance and market launch (Woxheal®, India 2020)
  • Core competencies include CMC development, formulation, packaging, technology transfer, laboratory design, process validation and process optimization
  • Provided tailored regulatory strategies, clinical study support and audit preparation services to ensure compliance and quality throughout the complete product lifecycle
  • Played a strategic role in supporting start-up and early-stage companies in shaping their development and patent strategies
  • Assisted innovators with corporate structuring, team building, fundraising strategies and partnering to transform novel scientific ideas into market-ready solutions
  • Combined scientific excellence, regulatory understanding, industry experience and strategic business insight to deliver measurable value to pharmaceutical and biotech companies aiming to develop and commercialize new therapies efficiently, safely and successfully
Mar 2006 - Mar 2024
18 years 1 month
Darmstadt, Germany

Managing Director and founding partner

CYTOPHARMA GMBH

  • Responsible for R&D and university collaborations in oncology, arteriosclerosis and infection indications
  • Oncology: developed active peptide-drugs to kill cancer cells (proof of concept in animal models)
  • Arteriosclerosis prevention with antibodies (cell culture systems and proof of concept in animal models)
  • Infection/Blood infection/Urinary infection: developed small molecule for injection, inhalation systems and template (cell culture, proof of concept in animal models, first-in-human study)
  • Developed patent portfolio and managed patent lifecycle
  • Performed general management duties, start-up development strategies, corporate and GmbH-law, and fundraising (~3.5 million Euro)
Sep 2004 - Jul 2024
19 years 11 months
Darmstadt, Germany

Managing Director, Head of Production and founding partner

DERMATOOLS BIOTECH GMBH

  • Developed and marketed an innovative drug for patients with non-healing wounds: diabetic foot ulcers, open leg and pressure ulcers
  • Designed and managed the development process, clinical phases, definition of timelines, milestones and KPIs
  • Managed project progress based on costs, quality and timelines, implementing corrective and preventive actions
  • Project management of preclinical and clinical development (SOP, CMC, IMPD, study protocol, DSUR)
  • Supervised and coordinated CDMO activities: production of API (DS), formulation (DP), packaging and final release of IP for clinical studies
  • Oversaw clinical development: CRO supervision, preparation and application to BfArM, FDA, DCGI and local Eastern authorities, and supervised clinical trials and training of local clinical staff
  • Set up and ran a production unit for API production in Germany according to GMP, ICH and AMG regulations, including all quality documentation, process validation (PPQ), staff training and internal/external audits
  • Drove continuous process improvement and SOP adaptation
  • Transferred complete drug production process from university lab to pharmaceutical market requirements
  • Managed tech transfer and ramp-up of production line with an Indian CDMO, providing regulatory and general support for WOXheal® launch in India (2020)
  • Presented and negotiated with regulatory authorities: BfArM, EMA, FDA, Indian DCGI and Eastern European authorities (including Georgia and Ukraine)
  • Led R&D early stage preclinical development of an anti-apoptotic peptide to treat severe wounds
  • Provided staff leadership, team building and motivation
  • Handled general management duties, start-up development strategies and fundraising (~30 million Euro)
  • Managed corporate and GmbH-law, budget planning and financial accounting
Jun 2000 - Sep 2021
21 years 4 months
Darmstadt, Germany

Chief Scientific Officer and founding partner

CYTOTOOLS AG

  • Structured and managed the R&D program and collaborations, and secured financing to advance drug candidates from discovery to market approval
  • Ran daily business activities and defined and implemented development strategies for the holding
  • Managed projects by defining timelines, milestones and KPIs
  • Coordinated and managed the R&D program, employee training, BMBF support program management and university collaborations
  • Developed patent portfolio and lifecycle management of patents
  • Handled investor communication and presentations
  • Prepared and executed the IPO at the Frankfurt Stock Exchange (stock price from €12 at listing to €70 max)
  • Organized annual shareholder meetings and reporting according to stock exchange rules
  • Managed risk through risk management and risk matrix development
  • Fostered international cooperation with partners for product development and marketing
  • Provided staff leadership and motivation, general management duties and start-up development strategies, and managed corporate and AG-law and corporate governance

Summary

Seasoned executive with a broad and comprehensive understanding of the entire pharmaceutical drug development process, from early laboratory research, GMP manufacturing, clinical phases I-III to market readiness and final product launch. Combines strategic vision with hands-on operational expertise to drive cross-functional teams and accelerate development timelines.

Proven track record of delivering results across technical, regulatory, administrative and legal domains, ensuring compliance and efficiency at every stage. Recognized for fostering collaboration between R&D, clinical, regulatory affairs and commercial functions to translate innovative science into successful therapeutic products.

Demonstrates a pragmatic, solution-oriented approach and the ability to navigate complex global environments, contributing directly to the successful and profitable advancement of pharmaceutical products from first concept to commercialization.

Skills

  • Drug Development And Production: Lab To Market

  • Cmc, Quality, Regulatory

  • Preclinical And Clinical Phases I-iii

  • Team-qualification, -Training Gmp, Sop

  • Collaborations (R&d) And Vendors (Cro, Cdmo)

  • Investor, Stakeholder Engagement

  • Wound Healing (Woxheal, Peptides)

  • Cardiology (Antibodies, Peptides)

  • Oncology (Peptides)

  • Blood Infection/sirs (Small Molecule)

  • Lung Infection (Inhalation)

  • Urinary Tract Infection

  • Microsoft Office Suite

  • Consense Forms And Gxp (Quality And Process Management)

  • Exploring Scientific Literature On Mechanical Forces, Apoptosis, Cell Survival, And Related Diseases

  • Hiking And Cycling Throughout Germany

  • Gardening And Home Improvement Projects

  • Cooking And Social Dining With Friends

Languages

German
Native
English
Advanced

Education

Sep 1995 - May 2000

Technical University of Darmstadt

Doctor of Engineering (Dr.-Ing.), Biotechnology · Biotechnology · Darmstadt, Germany

Oct 1989 - Sep 1995

Technical University of Darmstadt

Graduate Engineer · Chemistry, Chemical Technology and Biotechnology · Darmstadt, Germany

Aug 1984 - May 1987

Einhard Gymnasium Seligenstadt

General Higher Qualification for University Entrance · Seligenstadt, Germany

Need a freelancer? Find your match in seconds.
Try FRATCH GPT
More actions

Similar Freelancers

Discover other experts with similar qualifications and experience

Jürgen Schmickler
Jürgen Schmickler

Manager Manufacturing Operations USP

View Profile
Lars Koste
Lars Koste

Temporary Head of Quality Management & Regulatory Affairs

View Profile
Timur Güvercinci
Timur Güvercinci

Senior Quality Project Expert and Consultant in the Pharmaceutical Industry

View Profile
Niels Adams
Niels Adams

Consultant: Translational Sciences

View Profile
Salome Lassner
Salome Lassner

Senior Program Manager Transformation Office & Consultant

View Profile
Olivia Darmuzey
Olivia Darmuzey

Founder – Pharmaceutical Quality and Compliance Consulting Services

View Profile
Anja Żalik
Anja Żalik

Managing Consultant

View Profile
Thomas Freudemann
Thomas Freudemann

Operational Excellence Consultant

View Profile
Klaus Finneiser
Klaus Finneiser

Freelancer

View Profile
Marcel Pieles
Marcel Pieles

CAPA/Deviation/OOS Manager Solid Dosage Production

View Profile
Hans Spichiger
Hans Spichiger

Interim Manager, Consultant, Facilitator

View Profile
Jovan Jelic
Jovan Jelic

CSV Manager, Technical Engineering

View Profile
Andreas Seidl
Andreas Seidl

Interim Head of Risk Management and Usability

View Profile
Achim Dohl
Achim Dohl

Head of Operations

View Profile
Jan Kocma
Jan Kocma

GMP Consulting Expert

View Profile
Benjamin Kraus
Benjamin Kraus

MDR Transition with PRRC-Function

View Profile
Gerd Gembatzke
Gerd Gembatzke

Head of Quality Management and QM Taskforce

View Profile
Monika Weber
Monika Weber

Quality Specialist

View Profile
Josipa Ljubicic
Josipa Ljubicic

CEO/GxP Auditor

View Profile
Manuel Kathofer
Manuel Kathofer

Overall Project Manager for the Global Roll-Out of a Quality and Document Management System

View Profile
Desalegne Syit
Desalegne Syit

Medical Device Auditor (ISO 13485, ISO 9001)

View Profile
Joachim Bier
Joachim Bier

Consultant Medical Affairs & Clinical Affairs

View Profile
Isaac Udoh
Isaac Udoh

Global Head of Quality, Safety and Regulatory Affairs

View Profile
Honorata Donnermair
Honorata Donnermair

Lead Auditor/ Senior Product Specialist

View Profile
Anke Zampich
Anke Zampich

Consultant

View Profile
Chunnan Chen
Chunnan Chen

Freelance Consultant

View Profile
Estelle Kamwa
Estelle Kamwa

Document Management / Document Controlling Specialist

View Profile
Steffen Eschinger
Steffen Eschinger

Domain Lead FI, CO, HR, Investor Relations

View Profile
Lukas Hippel
Lukas Hippel

Board Member

View Profile
Dirk Bremen
Dirk Bremen

Freelance Interim Management

View Profile