Transition of biopharmaceuticals from research into process development and manufacturing
Identify the best technology platform for a cost-effective, reliable supply
Create a phase-appropriate strategy for process development and CMCnd CMC
Find the right partner to establish a suitable manufacturing network
With 25 years of international experience in the pharmaceutical industry, including research, bioprocess development, manufacturing, and strategy, I am familiar with potential obstacles and can support the rapid, seamless development of your biopharmaceutical product. My comprehensive expertise in CMC (Chemistry, Manufacturing, Control) and technology, coupled with my extensive network, enables me to develop and execute a long-term technical product strategy.
My Services
- Develop technical product strategies for biopharmaceuticals at different stages of their life cycle.
- Conduct CMC assessments and create phase-appropriate development concepts.
- Establish a robust and reliable manufacturing network and identify the right partners/CDMOs.
- Conduct technology assessments and support the selection and implementation of technology platforms.
- Develop and execute concepts for scale-up and technology transfers.
- Support the setup of an adequate CMC organization.
About me
I have led international, cross-functional teams of up to 145 members at Bayer Pharmaceuticals in Germany, the US, and Switzerland.
In my roles as scientist, plant manager, and department lead, I expanded Bayer’s biopharmaceutical pipeline and transferred several innovative products (antibodies, antibody fragments and antibody-drug conjugates) from research to early and late clinical development.
I improved business processes, optimized manufacturing networks, and adapted organizations to enable faster, cost-efficient product development.
As a leader of complex strategic programs, I have established new manufacturing concepts and technology platforms for biopharmaceuticals at multiple sites.
Education
- PhD in Biochemistry and Cell Biology (Max-Planck-Institute, Martinsried)
- Diploma in Chemistry (Ludwig-Maximilians-University, Munich)
- “Accelerated development program” (London Business School)
Professional Experience at Bayer
- Vice President Global Biotech Strategy
- Vice President Biologics Development
- Head of Biologics GMP Pilot Plant
- Senior Scientist Downstream Process Development
- Scientist Pharmaceutical Research
Contact
Let's talk and find out how I can support you.
Phone: +49 174 9293892
E-mail: felix@oehme-consulting.com
Address: Birkenhoehe 57, 42113 Wuppertal, Germany