AddressIncisive Technologies has developed BlueCheck, a novel “paint” that is used in the dental clinic to identify early-stage caries, the precursor to cavities. Incisive has grown from a university-led activity to a corporate enterprise consisting of a small team of 15 valued staff and consultants, committed to taking BlueCheck to the market. Oral health disease is the largest most chronic widespread disease in the world. BlueCheck has the attributes to fundamentally change and improve oral healthcare.
Our commitment is what unites our company.
The roleThe Production Scientist is responsible for supporting operational & quality requirements as part of the manufacture of products under supervision by the Operations Engineer or nominated manager. The role will support the formulation and processing of BlueCheck with particular attention to continual process improvement. In addition to the operational functions of this role, they will also support activities throughout the products’ lifecycle(s) and providing administrative and documentation assistance. The roles and responsibilities set out in this document are subject to review of management and may change, with consultation between impacted parties.
Key results areas - operations- Manufacturing of products in a GMP cleanroom environment
- Develop and look for efficiency gains in the business, support Continuous Improvement Programs (CIP) and drive a culture to reduce production defects
- Assist with verification and validation activities for process, software, or equipment IQ/OQ/PQ
- Support of process optimisation, scale-up and technology transfer activities, including preparation of relevant documents (protocols, study, plans, reports, batch records)
- Support risk management activities including process design/review and risk assessments
- Carrying out of other ad-hoc duties as directed by the Operations Engineer or nominated manager
- Organise shipments for Import/Export
- Material management (ordering, receipt, stocktaking, & invoicing)
- Reviewing quality-related documentation particularly in relation to operations activities
- Assist with deviations, out of specifications, CAPA and change control in the QMS with a focus on investigations and root cause analysis
- Monitoring test and production results/trends to support product quality reviews (PQRs)
- Take a proactive approach to team and personal professional development
- Identify opportunities for learning new skills
- Set personal goals for development and encourage an atmosphere of team improvement
- Offer and receive constructive feedback and criticism to and from anyone on the Incisive team
- Bachelor’s degree in chemistry, biochemistry, pharmacology, or substantially similar field
- At least two year’s full-time equivalent experience working in a laboratory setting in a regulated industry (medical devices, pharmaceuticals, cosmetics, food, etc.)
- Experience operating under a QMS according to ISO 9001, ISO 13485 or ISO 17025 or similar
- Meticulous record-keeping skills, ensuring all relevant aspects of manufacturing are captured and stored according to documented procedures
- Demonstrated experience in in contributing to investigational work
- Experience operating under ISO 13485 or ISO 17025
- Experience working in a manufacturing or operational capacity within a regulated environment
- Experience with protein chemistry or analyses of protein preparations
- Experience with Tangential Flow Filtration systems
- Participation or exposure to internal or external quality audits
