In this position you will be acting as the key interface between in-house technical development and external manufacturing partners for all technical aspects of process development. As such you interact with a variety of internal and external customers and helps to ensure the timely achievement of process development milestones in high quality. The focus of this position lays on scientific CDMO support, no hands-on laboratory work anticipated.
- Supervise and guide DS process development (cell line development, USP/DSP development, GMP production, process characterization, process validation), transfer and manufacturing at CDMOs
- Ensure that DS development is carried out with a focus on biosimilar development
- Act as a person in plant during crucial process development stages
- Review and provide crucial input to key DS development plans/reports (PC and PV reports, risk assessments, MBRs…)
- Act as internal DS development expert in cross-functional project teams and present DS development updates in internal meetings and in front of collaboration partners/sponsors
- Escalate project risks in a timely manner, elaborate alternative scenarios and strive for solutions
- Participate in the compilation of briefing books, INDs, IMPDs and BLAs
- Safeguard and expand knowledge on state of the art technologies in DS development and manufacturing
- Contribute to budget planning activities and IP-related discussions
Bring us your skills and energy, and shape your own career in a stimulating and open work environment. We are looking for highly motivated individuals who are ready to take on new challenges with enthusiasm and personal commitment. Working at Formycon means being part of a smart, innovative team with minimal hierarchy and opportunity to share your own ideas.
Have we sparked your interest? Then we look forward to receiving your application for employment through our online application portal. Please be sure to include all supporting documents, along with your earliest possible starting date and your salary expectations. We look forward to learning about you and the qualifications which you would bring to this position.