Senior Manager Quality Assurance (Lead): Advisor for Biotech Start-up companies in the field of Cell & Gene Therapy (ATMPs). Technical development strategies for GMP-manufacturing of patient-specific therapies and products with various applications. Manufacturing and release of GMP-batches for clinical trials (phase I,II). Supplier selection and qualification. Development & Improvement of individually adjusted GMP quality system. Authority inspections.
Interim Group-Manager Process Development (DSP): Development of GMP-manufacturing process for RNA-Vaccines (Drug Substance). Data assessement, problem solving, team building with the target of validation readiness (Clinical phase II,III). Technology transfer and scale-up.
Person-in-Plant (PiP): Commercial aseptic manufacturing of a Biosimilar (monoclonal antibody) in prefilled syringes (drug product). Investigation and root-cause assessment of quality issue at CMO for a global organization. Gap-assessment of GMP-compliance and risk assessment. Remediation strategy and monitoring visits at the external manufacturing site.
Senior Consultant: Inspection readiness (US-FDA) compliance of global organization of CAPA-system (EMEA-locations) Strategy, legacy overview, remediation and training of sites.
Lead GMP-Auditor Vaccine / Biopharma CMO-Development - Manufacturing DS/DP including suppliers. (Various customers) USP/DSP Process Development for clinical studies, Technology Transfers and commercial manufacturing. Training/Coaching of Junior-Auditors.
Interim Manager Process Validation / Human vaccine / biotechnological API-manufacturing / mammalian Cell-Culture. CMC-Technology Transfer to CMO - Clinical Phase III - New Product Launch (International organization), different risk assessments, including GMP-audits for supplier qualification and GMP-compliance support. [FDA Guidance for Industry "Process Validation" Stage 2: PPQ-Readiness and Validation]
Compliance-project: Inspection Readiness (FDA, EMA, etc.) - Remediation of Deviation/CAPA-system / subject matter expert / continuous improvement / root-cause investigations / product risk assessment etc. [EN ISO 13485:2012; FDA 21 CFR part 820; Class III sterile medical devices; human implants, etc.]
CMC - Technology Transfer (R&D to GMP-production, Clinical Phase III, New product launch), Risk Assessment, cleaning validation, statistical data assessment in aseptic biopharmaceutical manufacturing FDF - liquid sterile cartriges. [FDA-Guidance for Industry "Process validation" - Stage 1: Quality by Design - ICH Q8/Q9/Q10, etc.]
Senior Consultant: CAPA compliance / legacy review / remediation / subject matter expert in manufacturing of surgery implants, human biomaterials and combination products (class III medical devices), organization change management, investigations continuous improvements etc. (FDA-warning letter / Concent degree) [EN ISO 13485:2012; FDA 21 CFR part 820; Class III sterile medical devices; human implants & biomaterials, etc.]
Implementation of Continuous process verification (CPV) in aseptic manufacturing of biopharmaceutical / biologics drug product (liquid, lyo) according to FDA-Guidance for industry "Process validation" - Stage 3: Process Capability CpK-value, statistical data analysis [ICH Q9/Q10, etc.]
Hosting and guiding different inspections by authorities and for 'for cause audits` by large and medium pharma customers (CMO business). Including CAPA-Plan assessment.
Post aquisition audits (PAA) at worldwide sites after large company-merger. (Pharmaceuticals, diagnostics, medical devices) - including CAPA-plan assment and Quality Compliance.
Lead GMP-auditor - Compliance and "for-cause" audits of most cell culture media suppliers worldwide (Biopharmaceuticals, ISO 13485) - including CAPA-Plan assessment.
Lead auditor - International supplier qualification & supplier development for divers raw materials and single-use systems (ISO 13485) used in antibody manufacturing (USP/DSP - Biopharmaceuticals - DS/DP) - including CAPA-plan assessment and Quality Compliance.
International GMP-Audits (lead auditor) of contract manufacturers (CMO) for sterile finished dosage forms (cytostatics, biologics, biosimilars, etc. - syringes, vials, ampoules - liquid and lyophilized) including Quality Compliance.
GMP-compliance-Audits (lead auditor) of chemical API manufacturers in China [ICH Q7, etc.].
Senior QA-Manager - Technical QA-supervision of investment projects in pharmaceutical manufacturing (FOYA: factory of the year 2012 - single-use manufacturing facility).
Senior QA-Manager - Technical QA-supervision of cell culture development projects for manufacturing of antibodies/biologics [ICH Q7a, etc.] mammalian CHO manufacturing/ MCB,WCB / suppliers - including all aspects of Quality Compliance.
Manufacturing Scientist - New product launch New product launch in prefilled syringes: Process validation, qualification of equipment, technical trouble shooting, root cause investigations and risk assessments in aseptic biopharmaceutical manufacturing (FDF).
Manufacturing quality scientist - FDA-compliance of different technical projects in commercial pharmaceutical manufacturing, process design and trouble shooting.
Senior manufacturing expert - Continuous process verification (CPV) sterile manufacturing according to FDA-guideline using Minitab- Statistic software
Technical validation expert - Cleaning validation in biopharmaceutical manufacturing of API/Biologics/DS according to ICH Q7a etc.
Lead Auditor - GMP-Audits of manufacturers of disposable systems (polymer systems for biopharmaceutical manufacturing, ISO13485) - including CAPA-plan assessment and Quality Compliance.
QA-Expert -Training of GMP-personnel in risk assessments/ FMEA (aseptic biopharmaceutical processes DS/DP).
Technical qualification expert - Qualification (IQ,OQ,PQ) of pharmaceutical process equipment and utilities (WFI-systems, HVAC, etc.).
Process validation scientist - Product process validations (PPQ) biopharmaceutical manufacturing of Monoclonal antibodies/Mammalian cell culture/API/Biologics/DS (ICH Q7a).
QA-Manager (group lead) - Development of a GMP-system at a smaller biotechnology company - CMO. (Deviations, Change Control, Supplier qualification etc.) including all aspects of quality compliance.
Process Development Scientist - Development of a pervaporative Membrane bioreactor (R&D-Environment). Publication: Journal of membrane science (Elsevier)
Process Development Scientist - Development of a hollow-fiber bioreactor for expansion of hemopoietic stem cells CD34+ / mass transfer simulation. (company scholarship - R&D-Environment)
Process development scientist - Construction of prototypes for car -motor-cooling system (commercial launch).
Process scientist - Thermodynamic heat transfer calculations for pharmaceutical plant engineering (commercial product launch).