We are seeking a Senior Scientist for a Global Pharmaceutical company in Hessen focusing on Primary Packaging within their Medical Device R&D department.
The project is to ensure the stability of supply of primary packaging for the company - therefore the position will involve hands on testing of products to ensure their compatibility with the devices, Prefilled syringes, Stoppers, Vials and Reconstitution devices.
Location: Hessen with some home based flexibility if from outside of Germany - 30% lab work
Duration of employment: 2 Year Contract with potential of extension
Responsibilities as a Senior Scientist
*Evaluation, improvement, qualification and implementation of new/existing primary packaging materials & medical devices (extractables, leachables etc.)
*Maintain/establish and manage corporate relationships with suppliers, CROs and CMOs.
*Executing projects within the agreed time, quality and cost constraints
*Knowledge of the regulatory and quality landscape to ensure standard-compliant designs
*Work with quality management systems such as ISO 13485 and 21CFR820 Design Control,
*Risk management according to ISO14971, EU-MDD/MDR requirements, compilation (and maintenance) of design history files, verification and validation and support for clinical trials/commercial manufacturing.
Skills and Experience Required
*University degree, in a relevant scientific field, e.g. engineering, in biotechnology / biochemistry / biology or equivalent qualification based on professional experience in a relevant field.
*More than 5 years professional experience with quality management systems such as ISO 13485 and 21CFR820 Design Control
*Experience with risk management according to ISO14971, EU-MDD/MDR requirements, creation (and maintenance) of files on design history DHF
*Experience in verification and validation and support in clinical trials/commercial manufacturing.
*Strong scientific background in all aspects of primary packaging and drug delivery
*Experience with regulatory and quality standards and preparation of documentation to support quality assessments and for submission to regulatory authorities
How to apply
Apply here if you are interested in this opportunity please apply on the link below or if you would like a confidential discussion about your career opportunities please contact Isabel Kennedy of EPM Scientific.
Disclaimers: Must have the rights to Work in Germany
