Bavaria, Germany
Biopharmaceutical manufacturing expert (DS & DP) Successfully supported validation, submission and launch of Monjuvi Skilled in Good Manufacturing Practice (GMP), Change Control, Deviation management, Biotechnology, DS & DP manufacturing, Transfer and Validation projects as well as Projectmanagement
• Deputy for the Head of Manufacturing (according to german AMWHV §12) • Responsible for processing of change controls and deviations (Veeva) • DS and DP batch release • Selection of C(D)MOs and other external partners • Support continuous improvement of manufacturing processes (life cycle activities) • Participation in the design and evaluation of comparability studies • plus all aspects from Process Validation Expert position below
• Responsible for the validation of biopharmaceutical drug substance and drug product manufacturing processes in close cooperation with the CMOs involved • Contact person for involved CMOs regarding process validation and related topics • Oversight and responsibility for late stage development work packages • Participate in the preparation of submission documents (BLA, MAA, IND, IMPD) • Support DS and DP batch record review and release (master batch records and executed batch records) • Representation of area of responsibility in all functions anddepartments as well as with CMOs
• Technical and disciplinary leadership of the validation team • Definition of the validation strategy • Project management • Support during regulatory inspections
• Independent processing and supervision of Process validation projects • Preparation of risk analyses, validation plans and reports • Execution and documentation of validation activities • Creation of SOPs as well as procedural instructions for production • Implementation of changes by means of Change Control System • Creation of user requirement specifications • Support during regulatory inspections
• Responsible execution of validations for the production of biopharmaceutical active ingredients • Support in the establishment of new products in the commercial scale • Representation of Process/Cleaning Validation in project teams • Coordination of validation strategy and content with internal and external customers • Support in the preparation of regulatory documents
• Responsible management of process transfers into the GMP environment • Management of internal and external interfaces • Participation in trouble shootings and improvement projects • Preparation of development reports and presentation of results • Evaluation and establishment of new technologies • Independent planning and execution of experiments for the further development of cell culture media • Evaluation and interpretation of complex data sets