RESPONSIBILITIES : Lead late stage CMC Development of NBEs as well as supporting potential new indications Project Manage and Lead the CMC core team including tech transfers and up scaling activities as well as Process Characterization activities Ensure alignment and follow-
up with the functional leads / line managers (PS, MSAT, QC,QA, RA and Clinical Operations) and external consultants for timely execution of deliverables Serve as a point of contact for CMOs and CROs related to DS and DP manufacturing Present project status / risks / mitigations etc.
on a regular basis to senior CMC management team and relevant Global Stakeholders to secure alignment and structured decision making Author or review critical CMC documentation -
CMC development plans, regulatory submissions, minutes of internal and external meetings, QTPP, risk assessments etc. Prepare, follow and adjust the CMC project budget and resource forecasting Manage CTM supply according to the Clinical Development Plans as well as product disposition and inventory Serve as CMC representative in the Global Compound Development Team ensuring alignment between the CMC activities and the Program strategy and requirements and providing updates and proposed CMC strategy to the Program Team REQUIREMENTS : MSc / PhD or equivalent in biochemical engineering, biochemistry, biology, pharmacy or related discipline with 10 years or more of relevant biologics CMC (including project management) experience in an industrial setting In-
depth knowledge of current GMP guidelines, familiarity with regulatory authority submissions (IMPD / IND / BLA), quality and technical agreement drafting (CMO) Experience (hands-
on or theoretical) in process / analytical technology transfer and process scale up / validation Experience with drug development of Antibodies Experience with late stage development (Process Characterization and PPQ) Experience with PFS -
preferred Proficiency in state of the art project management tools Competencies : Disciplined, shows initiative, excellent planning and organizing, excellent communication, customer-
oriented, persuasive, problem analysis and solving, results orientated, teamwork, decisiveness Fluency in English, both written and spoken