Michael Firgens, MBA, PMP
Founder · Program Manager · Principal Consultant
PROFESSIONAL BACKGROUND
Michael is the founder of MF BIOTECH and advises and supports biotech and pharma companies on the development and approval of innovative biopharmaceutical products.
Michael has a 17+ year track record of managing development projects in the biotech and pharma industry. Since 2007, he has led and supported numerous biopharmaceutical development projects to successfully achieve key development milestones from early stage development to approval.
In 2019, Michael founded MF BIOTECH with the vision to provide best-in-class development support for innovative medicines. He has provided project leadership and tailored project solutions to companies from emerging startups to big pharma and has shaped high-performing project teams. He has established and executed product-specific development strategies for various biopharmaceutical product types, all at the forefront of medical innovation. Michael brings in practical hands-on experience for all technical areas to facilitate project execution. Michael is a guest speaker at Gläsernes Labor Akademie Berlin and a member of the CONELIS life science expert network.
Prior to founding MF BIOTECH, Michael worked in different international program management positions related to drug development and manufacturing within Fresenius Healthcare Group. He also worked as a Senior Consultant at Biopharma Excellence (now Pharmalex) where he contributed to numerous projects for innovative biotech products and significantly contributed to the company’s growth. Michael started his career in the area of clinical research as Clinical Project Manager and Clinical Research Associate at Sanofi-Aventis and Dr. Kade.
Michael received his Master’s degree in Biochemistry from the Freie Universität in Berlin. During his studies, he did research internships at the Max Delbrück Centre for Molecular Medicine (Berlin), the Centre for Molecular Neurobiology (Hamburg), the Harvard University Medical School (Boston), and the Institut Químic de Sarrià (Barcelona). Michael wrote his Master’s thesis on the project “Mechanism of chromatin remodelling by ATP-dependent complexes” at the Centre for Genomic Regulation (Barcelona). After his studies, Michael was trained as a Clinical Research Associate/Clinical Data Manager at Parexel. Michael also holds an MBA in General Management from the Wissenschaftliche Hochschule, Lahr. He graduated with the MBA Master Thesis “The Management of Ideas in the Front End of Innovation – a Case Study about the Creation of Innovation in the Pharmaceutical Industry“. Michael is a certified Project Management Professional and member of the Project Management Institute (PMI) as well as a core member of the PMI Community of Practice Life Science.
AREAS OF EXPERTISE
Preparation of integrated and product-specific development strategies
Project and program management
Preparation and conduct of scientific advice meetings and agency interactions (Europe, USA, Canada)
Orphan drug designations (Europe, USA)
Clinical trial applications, INDs (including submission management, IMPD, benefit-risk assessment, GMO documentation, responses to agency questions)
Marketing authorization applications (including submission management, QOS, Module 3, responses to agency questions during MAA procedures)
BIOPHARMACEUTICALS & PRODUCT TYPES
Protein drugs, monoclonal antibodies, fusion proteins
mRNA-based drugs and vaccines
Gene therapies, genetically modified organisms (GMOs), genome editing
Cellular immunotherapies
Regenerative therapies
Oncolytic viruses
Bacteriophages
Small molecules
First-in-class therapies
Orphan drugs
Biosimilars
Combination products
MEMBERSHIPS & CERTIFICATIONS
Let’s work together.
NETWORK
Drug development is teamwork, and MF BIOTECH works with a network of multi-disciplinary experts.
Join our network of experts at MF BIOTECH and collaborate with industry leaders to deliver cutting-edge solutions and drive innovation in the biotech sector.
CAREERS
Biopharmaceutical Development Consultant Trainee (m/f/d)
Berlin, Germany
WHAT YOU’RE APPLYING FOR
We’re looking for a Trainee who is excited to dive into all aspects of the biopharmaceutical development process in a structured 12-months training program.
You’ll be responsible for supporting a broad range of biopharmaceutical development programs, all at the forefront of today’s drug development. You’ll play a pivotal role in moving the program forward to achieve ambitious program goals.
You’ll also support the company growth of MF BIOTECH. Your ideas and entrepreneurship are welcome.
IN THIS ROLE YOU’LL
Support biopharmaceutical development projects from early development stage to approval
Contribute to the planning and execution of complex biopharmaceutical development plans
Support operational development activities that are critical to achieve development milestones
Lead marketing and business development initiatives that are vital for business growth and expansion
WHAT YOU’LL NEED
PhD or Master’s degree in a biological or life science related field
First work experience in the pharma and biotech or consulting industry
Superior analytical and organizational skills for complex problems or processes
Demonstrated intellectual curiosity, adaptability, independence, and business acumen
Professional communication and intercultural skills
Written and spoken fluency in English
CONTACT US