Beschreibung
For our Client in Basel, we are looking for a DD&C Primary Packaging Technology Expert, for 6 months contract.
Duration: ASAP to
Location: Basel
Workload: 100%,
Job Purpose:
- Lead and manage technical activities and apply expertise to address complex design, development and operational issues for the design development of primary packaging for combination products, processes and procedures.
- Compile Design Control documentation and contributing to a high quality Design History File (DHF).
- Author and Review of DHF relevant documents.
- Ensure quality and compliance to applicable regulations of the DHF elements of the assigned projects.
- Develop and optimize manufacturing processes for combination products.
Primary Packaging Technology Resonsibilities:
- Coordinate primary packaging development activities with the project team members for assigned projects
- Maintain knowledge in the areas of materials (glass, polymer, pharmaceutical rubber, silicone/lubricants, sterile barrier systems, adhesives).
- Manufacturing (injection moulding, glass converting, rubber moulding, assembly, fill & finish, transport validation)
- Develop primary packaging concepts to support early phase development
- Conduct feasibility assessments on new technology/packaging concepts
- Develop early and late phase primary packaging prototypes using rapid prototyping, machined and/or soft tooling
- Conduct design for manufacture assessments
- Conduct tolerance stack analyses
- Maintain technical drawings and models
- Contribute to risk analyses
- Develop Design Input Requirements
Candidate Background:
Education:
Minimum:
- BS/MS or equivalent
Desirable:
- Advanced degree in a scientific or relevant discipline (Ph.D. or equivalent).
Languages:
- Good knowledge of English (oral and written).
- Desirable knowledge of site language.
Experience/Professional requirement:
Successfully demonstrated min. 3 years of directly related experience:
- In sterile primary packaging or in the interface with drug development and primary packaging development.
Recognized expertise:
With the interactions between drug product and primary packaging in a specific area ie material, design development, primary packaging production processes, biomolecule primary packaging, ophthalmology devices
- Thorough knowledge of state-of-art technology/equipment/regulation as appropriate for the role.
- Thorough understanding of packaging and medical devices development processes
- Ability to work in and/or lead interdisciplinary and/or cross-cultural teams
- Proven leadership skills
- Strong communication skills, strong presentation skills and scientific/technical writing skills, advanced coaching skills
For further details please contact Aleksandra Sztajerowska:
E-mail: (see below)