30.09.2026 aktualisiert
100 % verfügbar
Senior Manager Biopharmaceutical Manufacturing
Ulm, Deutschland
Weltweit
Master's Degree in BiotechnologyÜber mich
10+ years in biopharma manufacturing (GMP, tech transfer, aseptic processing) — currently shop floor coaching. In deliberate transition toward People & Organizational Development, certified in change management & coaching (IHK, TÜV). The bridge between technical execution and people.
Skills
Six SigmaBiotechnologieBioverfahrenstechnikBioengineeringBiopharmazeutikaBioproduktionBiomedizinische TechnikBioprozessBusiness Process ManagementChange ManagementVerfahrenstechnikLebensmitteltechnologieHigh-Tech-FertigungBio-LebensmittelOrganisationsentwicklung
Tech Transfer & Process Validation
Expertise in tech transfer and validation of large-scale biopharmaceutical manufacturing facilities, including equipment qualification, process implementation in greenfield environments, and execution of process, cleaning and hold-time validations.
GMP Compliance & Batch Record Management
Extensive experience in planning and executing product-relevant Batch Records, reviewing and assessing BLA documentation for manufacturing parts, and ensuring cGMP compliance through evaluation of deviations and change controls.
Risk Analysis & Process Optimization
Proficiency in developing and executing detailed risk analyses (FMEA) for process safety and operational stability, as well as evaluating process changes and deviations to optimize yields and ensure regulatory compliance.
Large-Scale Bioreactor Operations
Hands-on experience with large-scale mammalian cell culture manufacturing, including 2x15,000L main bioreactors, media preparation, IPC-equipment, and BRX 20,000L operations.
Qualification Engineering
Execution of comprehensive qualification and calibration projects for pharmaceutical manufacturing, ensuring equipment readiness and GMP compliance in line with the highest industry standards.
Process Control Strategy Development
Contribution to defining process control strategies for large-scale mammalian cell cultures, including creation of Master Batch Records and setting process parameters for global production transfers.
Siemens SIMATIC Batch CC
Knowledge and application of Siemens SIMATIC Batch CC in biopharmaceutical manufacturing environments.
Six Sigma Methodology
Certified White Belt in Six Sigma methodology, enabling structured approaches to process improvement and quality management.
Agile & Change Management
Certified Professional Scrum Master (PSM I) and Change Manager (IHK), with expertise in facilitating agile teams, guiding organizational transformation processes, and strategic learning design.
Documentation & Compliance Management
Skilled in managing documentation from initial drafting to final approval, including review of executed batch records (EBRs) and manufacturing documentation for completeness and compliance.
Expertise in tech transfer and validation of large-scale biopharmaceutical manufacturing facilities, including equipment qualification, process implementation in greenfield environments, and execution of process, cleaning and hold-time validations.
GMP Compliance & Batch Record Management
Extensive experience in planning and executing product-relevant Batch Records, reviewing and assessing BLA documentation for manufacturing parts, and ensuring cGMP compliance through evaluation of deviations and change controls.
Risk Analysis & Process Optimization
Proficiency in developing and executing detailed risk analyses (FMEA) for process safety and operational stability, as well as evaluating process changes and deviations to optimize yields and ensure regulatory compliance.
Large-Scale Bioreactor Operations
Hands-on experience with large-scale mammalian cell culture manufacturing, including 2x15,000L main bioreactors, media preparation, IPC-equipment, and BRX 20,000L operations.
Qualification Engineering
Execution of comprehensive qualification and calibration projects for pharmaceutical manufacturing, ensuring equipment readiness and GMP compliance in line with the highest industry standards.
Process Control Strategy Development
Contribution to defining process control strategies for large-scale mammalian cell cultures, including creation of Master Batch Records and setting process parameters for global production transfers.
Siemens SIMATIC Batch CC
Knowledge and application of Siemens SIMATIC Batch CC in biopharmaceutical manufacturing environments.
Six Sigma Methodology
Certified White Belt in Six Sigma methodology, enabling structured approaches to process improvement and quality management.
Agile & Change Management
Certified Professional Scrum Master (PSM I) and Change Manager (IHK), with expertise in facilitating agile teams, guiding organizational transformation processes, and strategic learning design.
Documentation & Compliance Management
Skilled in managing documentation from initial drafting to final approval, including review of executed batch records (EBRs) and manufacturing documentation for completeness and compliance.
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2026
Sprachen
DeutschMutterspracheEnglischverhandlungssicher
Projekthistorie
Focusing on talent acquisition, strategic learning design and competency management. Specializing in organizational development and guiding transformation processes as Change Manager (IHK). Certified expertise in facilitating and coaching agile teams as Professional Scrum Master (PSM I).
Key expert in tech transfer and validation of a new-build large-scale facility featuring 2x15,000L main bioreactors. Reviewing and gap assessment of BLA for manufacturing parts. Directed equipment qualification and process implementation in greenfield environments (Mediapreparation & Harvest). Responsible for planning and executing product-relevant Batch Records, process deviations, validations, including process, cleaning and hold-time validation. Performed gap analyses and risk evaluations (FMEA).
Global production transfers - creating relevant manufacturing instructions and setting process parameters for large scale 2x15,000L. Developed and executed detailed risk analyses for process safety and operational stability. Contributed to defining process control strategies for large-scale mammalian cell cultures as well as creation of Master Batch Records. Evaluated process changes and deviations to optimize yields and ensure cGMP compliance.