Senior Process Scientist (m/f/d)

DAS UNTERNEHMEN

For one of our innovative, world leading biopharmaceutical clients of high-quality biosimilars in Bavaria we are looking for a Senior Process Scientist (m/f/d).
 

IHRE AUFGABEN

•Supervise and guide DS (drug substance) 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 (process characterization and process validation reports, risk assessments, MBRs (master batch records), etc.)
•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 Your responsibilities:

•Supervise and guide DS (drug substance) 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 (process characterization and process validation reports, risk assessments, MBRs (master batch records), etc.)
•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

IHR PROFIL

•Degree in process sciences, biotechnology, biology, chemistry, biochemistry or a related field
•Ideally a minimum of 3 years’ experience in the biopharmaceutical industry or a highly related field
•Applied in-depth knowledge of Process Sciences (cell line development, USP and/or DSP)
•Passion to deliver against tight timelines
•Experience in people management (matrix and/or line function setting) is considered advantageous
•Fluent in written and spoken English. Basic German knowledge is considered advantageous
•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