Principal Scientist / Respiratory Devices
- Recruiter
- Confidential
- Location
- Canterbury
- Salary
- Competitive
- Posted
- 10 Jun 2022
- Closes
- 08 Jul 2022
- Sectors
- Travel & Tourism
- Contract Type
- Permanent
- Hours
- Full Time
Principal Scientist / Respiratory Devices
GBPhighly competitive salary on application (experience & qualifications dependent) + relocation package on offer + annual bonus incentive + Pension + Life Assurance + Health Insurance + innovative and collaborative global working environment
We are looking to engage with a Principal Scientist / Respiratory Devices to assist a successful, global pharmaceutical business develop their Medical Devices / Inhaled Medicines portfolio for patients worldwide
Principal Scientist / Respiratory Devices key responsibilities include:
* Act as Subject Matter Expert (SME) supporting the development of respiratory devices from program initiation through to regulatory submission
* Assess device functionality and combination product performance from early-stage device design
* Technical interface between drug product and device teams during combination product development ensuring formulation and manufacturing development activities are aligned
* Develop design requirements and specifications based on characterization of comparator products, regulatory requirements, design intent and user requirements
* Develop test methods and specifications to assess device functionality and product performance
* SME for metrology testing and defect analysis to support component molding process development and qualification
* Responsible for material assessment of device components including biological evaluation, extractables profiling and material certification
* Provide expert technical support to manufacturing sites during filling and assembly process development
Principal Scientist / Respiratory Devices profile
* Masters / Degree in Science with recent experience in research and development of respiratory products
* Previous experience as SME / Scientist in a regulated, GMP environment
* Experience developing test methods and specifications to assess device functionality and product performance
* Experienced in application of statistical techniques for data analysis
* Experience writing and supporting regulatory submissions
* Highly driven and motivated individual who can work as part of a dynamic team whilst taking responsibility for individual tasks in a Subject Matter Expert role.
* Able to lead discussions & communicate complex technical and/or project information to key stakeholders
* Some travel required to HQ sites in Europe / globally, 1-2 per month
This Principal Scientist / Respiratory Devices role is an exciting opportunity to join a successful global Pharma business with a growing portfolio of products, so please send us your profile and one of our consultants will be in touch
GBPhighly competitive salary on application (experience & qualifications dependent) + relocation package on offer + annual bonus incentive + Pension + Life Assurance + Health Insurance + innovative and collaborative global working environment
We are looking to engage with a Principal Scientist / Respiratory Devices to assist a successful, global pharmaceutical business develop their Medical Devices / Inhaled Medicines portfolio for patients worldwide
Principal Scientist / Respiratory Devices key responsibilities include:
* Act as Subject Matter Expert (SME) supporting the development of respiratory devices from program initiation through to regulatory submission
* Assess device functionality and combination product performance from early-stage device design
* Technical interface between drug product and device teams during combination product development ensuring formulation and manufacturing development activities are aligned
* Develop design requirements and specifications based on characterization of comparator products, regulatory requirements, design intent and user requirements
* Develop test methods and specifications to assess device functionality and product performance
* SME for metrology testing and defect analysis to support component molding process development and qualification
* Responsible for material assessment of device components including biological evaluation, extractables profiling and material certification
* Provide expert technical support to manufacturing sites during filling and assembly process development
Principal Scientist / Respiratory Devices profile
* Masters / Degree in Science with recent experience in research and development of respiratory products
* Previous experience as SME / Scientist in a regulated, GMP environment
* Experience developing test methods and specifications to assess device functionality and product performance
* Experienced in application of statistical techniques for data analysis
* Experience writing and supporting regulatory submissions
* Highly driven and motivated individual who can work as part of a dynamic team whilst taking responsibility for individual tasks in a Subject Matter Expert role.
* Able to lead discussions & communicate complex technical and/or project information to key stakeholders
* Some travel required to HQ sites in Europe / globally, 1-2 per month
This Principal Scientist / Respiratory Devices role is an exciting opportunity to join a successful global Pharma business with a growing portfolio of products, so please send us your profile and one of our consultants will be in touch