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.
Requirements
* 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
* 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
* Safeguard and expand knowledge on state-of-the-art technologies in DS development and manufacturing
* Contribute to budget planning activities and IP-related discussions
Knowledge / Skills / Abilities:
* 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
