Our Melbourne based facility is seeking a Senior Scientist to oversee the product development activities, within assigned projects, for the translation of biological assays and other biological processes into a microfluidic, IVD environment. This is your chance to join a rapidly growing multinational medical devices company working on the leading edge of medical diagnostics and life-science.
In this role you will be responsible for assay related development tasks within IVD Product Development projects. The projects you will work on may range from the development of new and novel life science research devices to rapid point-of-care diagnostic products.
In addition, this role will also oversee the design transfer of assay related processes to Manufacturing. This role will play an integral function in product development projects and be required to manage internal and external stakeholders, consult into projects, mentor and coach staff, and contribute to continuous improvement activities for enhanced effectiveness and efficiency of the product development process. As required, the role will provide cross-functional support to Business Development and Manufacturing activities.
Reporting directly to: Bioscience Team Leader or Head of Bioscience
Essential Skills and Requirements:
- In depth experience (minimum 10 years) with product or assay development under a Quality Management System with intimate understanding of Design Control, and Verification and Validation processes (ISO13485 would be ideal)
- A tertiary qualification (Masters/PhD desirable) in biology, biochemistry, immunology, molecular biology, biotechnology or life sciences related discipline.
- Extensive understanding of GMP requirements
- Demonstrated ability in experimental design, data analysis, scientific report writing and presentation skills
- Proficient computer skills, including Microsoft Office Suite and statistical/analytical programs (e.g. GaphPad, JMP)
- Experience working in fast paced, innovative, high quality, regulated environment such as medical device, pharmacological, or similar industry is essential. IVD assay development experience would be ideal.
- Excellent attention to detail and self-motivation to deliver work to the highest standards
- Ability to multitask, plan, schedule, coordinate, manage time efficiently, and problem solve effectively
- Excellent written and verbal communication skills, teamwork and ability to take initiative
- Must be practically minded and hands-on
Key Responsibilities and Deliverables:
- Interpret and translate assay workflows into product requirements and work closely with the engineering team to guide, from a bioscience perspective, the development of design concepts, components, assemblies, and products in compliance with applicable quality system procedures, industry and business standards, and regulations.
- Develop, scope, and estimate resources for Work Packages as part of project acquisition process and following subsequent project delivery stages, to successfully deliver projects, from a bioscience perspective, within scope, with quality, and within allocated timeframes and budget.
- Adhere to the principles of the engineering process discipline to achieve bioscience related project deliverables, including but not limited to requirement definition, concept generation, product design and development, risk management, cost modelling, DFM, and design verification.
- Employ data driven tools and methodologies to implement structured and timely problem solving.
- Identify opportunities and develop recommendations, from a bioscience perspective, to improve product/design efficiency.
- Develop and champion the implementation of workflows to ensure best scientific practises are adhered to within the PD process and cross-functional team activities
- Provide subject matter expertise to guide project teams through the selection of correct design/ manufacturing concepts and fundamental technology to ensure successful project outcomes.
- Liaise closely with the NPI Engineering and Manufacturing teams to successfully transition projects from Product Development into Manufacturing.
- Organize plans and create schedules to identify priorities, achieve project timelines, and meet project budgets.
- Support the recruitment, coaching and development of Bioscience staff to achieve excellence and efficiency
- Interact with clients on an as-needed basis to support project and sales activities.
- Collaborate with key stakeholders, managers, and wider product development, manufacturing, and purchasing teams
- Manage internal and external suppliers required to support product development tasks
- Attention to detail and self-motivation to deliver work to the highest standards
- Multitasking, planning work, scheduling tasks, coordinating activities, and managing time efficiently
- Timely problem solving using data driven tools and methods
- Presentation of assay translation data and/or issues both internally to stakeholders and externally to clients.
Working at SCHOTT MINIFAB
SCHOTT MINIFAB is a global leader in medical diagnostics and lifescience product development and manufacturing. We form part of SCHOTT AG, a 130 year old company with 16,200 employees and 34 locations worldwide.
To apply please submit your CV and cover letter: