Dirk Kaiser
Freelancer, Owner
Experience
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
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)
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
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
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 Biotechnology (26 years) and Pharmaceutical (26 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 Product Development (26 years), Research and Development (26 years), Project Management (24 years), Production (20 years), Strategy (18 years), and Quality Assurance (16 years).
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 Market
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
Education
Technical University of Darmstadt
Doctor of Engineering (Dr.-Ing.), Biotechnology · Biotechnology · Darmstadt, Germany
Technical University of Darmstadt
Graduate Engineer · Chemistry, Chemical Technology and Biotechnology · Darmstadt, Germany
Einhard Gymnasium Seligenstadt
General Higher Qualification for University Entrance · Seligenstadt, Germany
Profile
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