Senior Process Scientist Upstream (m/f/d)
Ansprechpartner
Branche
Biotechnologie
Berufsfeld
Manufacturing
Region
Bavaria
DAS UNTERNEHMEN
For one of our innovative, world leading biopharmaceutical clients of high-quality biosmiliars in Bavaria we are looking for a Senior Process Scientist USP (m/f/d).
In this exciting role you will be acting as the key interface between in-house technical development and external manufacturing partners for all technical aspects of process development.
You will interact with both internal and external customers to ensure process development milestones are achieved with high quality and on time.
You will focus on scientific CDMO support, no hands-on laboratory work anticipated.
In this exciting role you will be acting as the key interface between in-house technical development and external manufacturing partners for all technical aspects of process development.
You will interact with both internal and external customers to ensure process development milestones are achieved with high quality and on time.
You will focus on scientific CDMO support, no hands-on laboratory work anticipated.
IHRE AUFGABEN
- Responsible for overseeing and directing DS process development (cell line development USP/DSP development, process characterization, process validation) in a GMP regulated environment, transfer, and manufacturing at CDMOs
- Ensure DS development is performed with a focus on biosimilar development
- Act as point of contact in the plant during critical process development phases
- Responsible for reviewing key DS development plans/reports (PC and PV reports, risk assessments, MBRs…).
- Transfer of DS development updates as a DS development expert to internal projecteams and collaboration partners
- Work in a solution-oriented manner and create alternative scenarios to escalate project risks in a timely manner
- Participate in the creation of briefing books, INDs, IMPDs, and BLAs
- Participate in budget planning activities and IP-related discussions
IHR PROFIL
- Degree in process science, biotechnology, biology, chemistry, biochemistry, or a related field
- Very strong experience in the biopharmaceutical industry or a strongly related field
- Strong and in-depth knowledge of process science (cell line development, USP and/or DSP)
- Ability to meet tight timelines
- Experience in people management (matrix and/or line function) is a plus
- Fluent in spoken and written English is a must have, German is a plus
- Work permit for Germany is mandatory
BENEFITS
- Excellent work and company culture
- Working in an exciting scientific environment
- A dynamic and innovative working field in a motivated international team
- Working in the heart of Bavaria
- Flexibility and additional social benefits