For our Recombinant Product Development department we are looking for a
Sr Mgr PRD Packaging & Devices (f/m)
(full-time / permanent)
Our Medical Device and Primary Packaging Development organization is focused on the design, development and commercialization of a diverse portfolio of device technology solutions to enable delivery of CSL’s innovative therapies that improve patients' quality of life, solve unmet medical needs and save lives. The Senior Manager of the Primary Packaging and Medical Devices (PPMD) Team, Marburg, is responsible for the selection, evaluation, improvement, verification and implementation of new / existing primary packaging materials & medical devices for CSL Behring products
Main Responsibilities and Accountabilities
- Lead a Team in the evaluation and characterization of primary packaging and drug delivery devices as well as providing supervision of direct reports including mentoring, career development, task allocation, workload prioritization, workface planning and annual performance reviews
- Responsible for the selection, development and evaluation of primary packaging materials and medical devices – in cooperation with internal departments and external partners
- Execute projects within the agreed time, quality and cost constraints, resulting in state-of–the-art drug delivery devices.
- The Senior Manager will apply their knowledge of the regulatory landscape to ensure standard compliant designs, working to Quality Management Systems such as ISO 13485, and 21CFR820 Design Control, risk management to ISO14971, EU MDD/MDR requirements, compilation (and maintenance) of Design History Files, verification and validation and clinical trial/commercial manufacture support.
- Establish and manage key company relationships with suppliers, CRO’s, CMO’s and standardizing Committees.
- Support supplier audits and due-diligences of suppliers.
- Provide leadership to PPMD to deliver submission-ready packages.
- Author technical specifications, design control documentation (Design Development Plans, User Requirements Specifications, Design Inputs, Design Outputs, Design Verification Plans), conformity assessments and risk management documentation.
- Application of theoretical engineering knowledge to establish robust technical product requirements and to develop engineering design solutions to assure devices maintain the required level of performance throughout the life of the product.
- Provide subject matter expertise to multi-disciplinary functions including, QA and Regulatory. Provide responses to questions raised by regulatory bodies.
- Analyze data using advanced statistical techniques and communicate results to a cross-functional team
Qualifications / experience
- Studies of natural sciences (pharmacy, biology, medicine) or technical engineering (biomedical, process or mechanical engineering)
- At least 10 years proven track record in drug delivery device development (Experience in working in a global pharmaceutical company or medical device manufacturer)
- Experience in project management
- In-depth understanding of design control and risk management. Proficiency with 21 CFR Part 820, ISO 14971
- Experienced in creating, reviewing, and editing, Design Control Documents (Design History Files and Technical Files content) for Combination Product and Medicinal Product.
- Strong Technical Leadership and a team player with good mentoring skills
- Proficiency in English. German Preferred.
- Knowledge of Stability Studies, Compatibility studies and long-term functionality testing
If you are interested in this challenging position, please apply via our website.
CSL Behring GmbH
Position number: R-065185
Worker Sub Type: