4 days ago

DD&C Primary Packaging Technology Expert

Harvey Nash AG

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DD&C Primary Packaging Technology Expert

For our Client in Basel, we are looking for a DD&C Primary Packaging Technology Expert, for 6 months contract.

Duration: ASAP to 31/08/2018

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:

  • Minimum: BS/MS or equivalent
  • Desirable: Advanced degree in a scientific or relevant discipline (Ph.D. or equivalent).


  • 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 i.e. 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: aleksandra.sztajerowska@harveynash.com
Tel: +41435088643

Harvey Nash AG
Aleksandra Sztajerowska
+41 44 296 8844