Project Development Specialist – R&D (m/f)

Project Development Specialist

The context

The project development specialist will ensure overall success of Product Development projects in R&D. This position requires communication and technical skills to enable oversight of multiple, related projects or complex R&D programs, to achieve project goals and on time delivery in alignment with the companies strategic goals. You directly report to the Vice-President R&D.

Your missions

• You drive product development projects in the field of biotechnological API manufacturing (enzymes, proteins, peptides, etc.) from initiation in the lab (e.g. research and project writing) to implementation of pilot manufacturing.

• You drive development projects from customer need and idea-generation to pilot- and industrial scale-up/role-out stage, whereby your focus is on the needs of the customer or patient.

• You develop project plans, identify and analyze risks, constraints and resource requirements and build and assess time estimates.

• You coordinate and ensure successful on-time completion of cross-functional development projects that may span functions, organizations, geographic regions and cultures.

• You maintain full control of project scope of assigned development projects.

• You collect and analyze customer feedback concerning the developed product and processes and translate the results into a technical product/process definition.

• You analyze and organize prototype and pre-clinical application trials within the R&D team to evaluate prototype performance and safety.

• You plan and follow up pilot trials and industrialscale-up trials in production.

• You develop effective relationships and maintain communication with stakeholders at multiple levels, including those external to the organization.

You directly report on project progression to the Vice-President R&D.
R&D System flows:

• You will prepare and maintain full documentation for R&D design and development administration and procedures, in accordance with relevant SOPs, GxP and ISO standards.

• You will write engineering, biocompatibility, SDS and other reports related to the product development project and create presentations when required.

• You will participate in the company-wide innovation management processes, including projects outside the direct scope of the function and provide close support to the Vice-President R&D

• You will participate in product portfolio road mapping exercises and product development concept phases.

• You are willing to gain specific technical knowledge through contacts with internal and external stakeholders and through literature, patents and seminars.

Your profile & qualifications:

The profile, knowledge, experience and skills required for that role

• You hold a degree or PhD in Bio-engineering, Biomedical engineering, biotechnology, etc. or comparable scientific technical background

• You have experience with Biotechnological manufacturing processes (enzymes, proteins, peptides, antibodies, etc.)

• You are driven by a desire to improve patients’ health

• You are convinced that biotech innovation, correctly designed and developed, can improve patients’ lives helping them to live the life they love.

• You have an understanding of functional and technical pharmaceutical, medical device and/or digital project development processes and innovation processes

• You are enthusiastic about product development and driving multidisciplinary project teams (cross-functional teams, multiple projects, multiple types of products, etc.)

• You are fluent (written and verbal) in English