Strong expertise in composing toxicological reports and test methods as well as selecting appropriate tests
Management experience within a management range of 3 - 60 people
In addition to his technical expertise, this expert is also convincing due to his open manner and noticeable passion for the topics of biocompatibility and sterilization
He is currently on a project via K-Recruiting (as Interim Head of Biological Safety) and we have only received excellent feedback
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- Dr. rer. nat. Diploma-Biology / Toxicology
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Biocompatibility, Sterilization/Hygiene, Toxicology, Test Design, Test Execution, Process Development, CAPA, Batch Release, Small Batch & Large Scale, Pharma, Medical Devices
Key-Facts
Extract from previous activities
Medical Devices Company, Germany (via K-Recruiting)
Interim Head of Biological Safety
Interim leadership of the biosafety team
Development of technical or technological solutions and continuous process improvement in the field of biosafety
Selection of suitable test equipment and description of test methods, test set-up and execution as well as review of test specifications in the area of biological safety
Medical Devices Company, Germany
Regulatory Expert
Toxicological material evaluation
Development and implementation of suitable test strategies for approval in EU and USA according to MDR and FDA
Change management
Preclinical testing of biocompatibility
Development and validation of suitable sterilization processes
Preparation of biological evaluation plans
Study monitoring
Medical Devices Company, Germany
Expert for Toxicological Consultation
Assessment, toxicological consultation and evaluation of complex mixtures of leachable and extractable substances from pharmaceutical and medical device production
Medical Devices Company, Germany
QA-Manager Sterilization and Hygiene
Expert for Sterilization
CAPA-Management
Batch-Release
Pharmaceutical & Medical Devices Company, Germany
R&D Expert
Responsible for all questions regarding biocompatibility (ISO 10993)
Conceptualization of biocompatibility from a scientific and regulatory point of view
Chemical characterization (GC/MS, LC/MS, ICP) and evaluation of raw materials and injection molded assemblies (GLP)
Study monitors for internal and external analytical studies (GLP, GMP)
Toxicological evaluation of changes, deviations and leachables & extractables
Responsible for all questions regarding sterility and sterilizability
Development and validation of suitable sterilization processes (small batch and large scale) (GMP, ISO 17025)
Study monitors for internal and external release-relevant studies (bioburden, endotoxins, pyrogenicity, particles, etc.
Responsible for all questions regarding compatibility of the medical device with the drug product
Conceptualization of drug compatibility under scientific and regulatory aspects