Combination Product Development Expert (Parenteral Drug Delivery) in Allschwil

Laura Deola, Basel Professionals Health Care & Life Sciences
jetzt bewerben

job details

Allschwil, Basel-Stadt
Life Sciences
Laura Deola, Basel Professionals Health Care & Life Sciences
058 201 55 50


Randstad Professionals is looking for a Combination Product Development Expert for Parental Drug Delivery for a client based in Allschwil.

Contract Duration: 6 months

Start Date: 01.12.2020


Your responsibilities for this position would be:

  • Within a combination product development project, responsible for the design control documentation and stage completion from clinical study readiness to commercial launch to meet business objectives

  • Provide sound project planning management, technical & engineering expertise to develop and introduce the new combination product for clinical phase and commercial launch

  • Lead and Execute internal technical Design Development and Engineering activities & tasks defined for the combination product including GMP technical documentation management, support to Regulatory filings and maintaining inspection readiness

  • Effectively collaborate with all project functions and communicate technical requirement for development and industrialization of the product

  • Ensure compliance with all local, state, federal, and companies quality policies, procedures and practices, safety regulations, policies, and procedures

  • Combination Product Design Control process:

    • Timely plan and lead Design and Risk reviews for clinical study readiness, including creation of supportive documentation required prior and during review meetings, as well as review reports

    • Create and maintain up to date internal Design Control files, including technical writing of applicable design control documentation (e.g. design input requirements, design verification and design validation plans and reports)

    • Support Risk management process, including writing and leading of supportive design FMEAs

  • Combination Product Technical Design Development and Engineering activities:

    • Lead and ensure (self)-execution of internal characterization or design verification studies for the combination product in collaboration with internal network

    • Deploy statistical analysis to ensure and demonstrate product robustness

    • Timely lead technical issue resolution and effective solution implementation in collaboration with suppliers, service providers and internal network

    • Create and Lead design FMEAs

    • Support creation of technical supply specification

  • Product technical development planning:

    • Support creation of MDCP product development time bound plan and ensure quality and accuracy to support integrated project plans encompassing all cross-functional activities supporting technical deliverables

    • Engage in detailed review of technical plan with project cross-functional team and be accountable for their success

  • Support elaboration of budgets / spending for activities in accordance with project and department plans

  • Technology transfer: Organize and communicate to ensure efficient and effective transition from research to development to manufacturing

  • Actively seek training to improve skills.  Ensure technical lessons are reviewed, learned, and disseminated.  Actively teach and promote and reward learning

  • Demonstrate strong and clear accountability for Product and Industrial scale-up performance and delivery, and effective supplier management

  • Willingness to self-perform “hands-on” tasks

  • Conduct and encourage frequent formal and informal communication within the team to ensure full engagement, support and efficient operation

  • Able to demonstrate strong persuasion and timing skills

  • Leadership courage, demonstrate and promote leadership courage by doing what is right

  • Dealing with ambiguity, demonstrate agility and action orientation when facing change and uncertainty.

This sound interesting to you? If yes you should have the following requirements:

  • Demonstrated combination product design control and technical development skills preferably in the field of parenteral delivery systems (pre-filled syringes, needle-based injection systems)

  • Minimum 7 years of experience in engineering/technical field, with 5 years demonstrated combination product development in pharmaceutical industry with successful track record of delivering combination products to clinical studies and/or market

  • Undergraduate degree in related engineering field, advanced degree desired

  • Advanced Problem-solving skills and sound statistical knowledge and associated system (e.g. minitab)

  • Broad and deep understanding of disciplined combination product development processes, regulatory, and quality requirements

  • Fluent in English is a must

  • Strong skills in project planning and management

  • Ability to use Computer Aided Design (CAD) systems. (e.g SolidWorks…) is a plus

Did we spark your interest? We are looking forward to receiving your online application.

Please note a Swiss work permit or EU/EFTA citizenship is mandatory for this position.