- Experience Level
- Experienced (non-manager)
On behalf of my client I am recruiting for a Senior Scientist, for the New Product Introduction Group.
The team are part of the Product Engineering Group and is responsible for R&D, new product introduction, product transfer, design changes, product improvements as well as the provision of technical support to the Manufacturing and QC departments. The primary focus in the role is the development of new lateral flow products for the infectious disease markets.
• Technical development and being the subject matter expert
• Driving the delivery of technical transfer, project management and validation activities for new products from R&D or third parties into the company.
• Providing technical support for lateral flow Manufacturing and QC depts.
• Facilitating the resolution of technical issues by leading, designing and executing root cause investigations in a timely manner.
• Being proactive in problem identification and process improvement by trending of manufacturing data and ongoing monitoring of product robustness.
• Working to deadlines, both individually and as part of a team to ensure milestones are met.
• Demonstrating commitment to the organisation’s quality policy and adherence to the quality system.
• Providing assistance as required to other company product areas.
• May act as project leader, lead scientist, or independent reviewers
• A minimum degree in Biological/Biomedical Sciences, Microbiology, Biotechnology, Biochemistry or Chemistry, (MSc and/or PhD with post-doctoral experience would be preferred)
• A minimum of 3 years’ experience within the in vitro diagnostic industry with extensive hands on laboratory experience in vitro diagnostic product development.
• Experience in project management, stakeholder accountability and milestone delivery is essential.
• Experience in the design and development of in vitro diagnostics within a certified design control process.
• Experience in protein conjugation and protein coating on nitrocellulose membrane is essential.
• Experience in handling blood based samples and infectious disease agents.
• Experience in CE Mark/WHO and/or FDA regulatory requirements.
• Excellent communication skills, (both written and verbal), interpersonal and presentation skills, and be team focused.
• Ability to lead cross-functional teams and hold stakeholders accountable for deliverables.
• Ability to make decisions based on technical understanding to ensure that products are technically sound and meet quality requirements