Principal Scientist, Product Development - Lateral flow
DO WORK THAT MATTERS.
At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.
Abbott Rapid Diagnostics (formerly Alere) is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies.
We have an exciting opportunity for a Principal Scientist, (Product Development) - Lateral flow within our Infectious Disease Developed Markets business unit located at Scarborough, ME. In this role, you will be instrumental in providing technical expertise to the design and development of new single use In-Vitro Diagnostic (IVD) tests.
Principal level Scientist and Subject Matter Expert on protein conjugation and polymer sciences (Nitrocellulose membranes) for lateral flow products; serves as a Technical Lead on methods and process development, while providing leadership to junior level Scientists. Plans and conducts work requiring in-depth understanding of novel techniques or ingenuity in selecting and evaluating approaches to unforeseen or novel problems. Has strong and demonstrated abilities in critical thinking, attention to details, statistical analysis, and problem solving.
Provides expertise on materials selection, characterization of raw and treated materials, develops new methodologies and processes. Works with R&D teams across sites from concept to market release. Conducts studies to determine the ability of the materials/process to function as intended. Maintains detailed documentation throughout all phases of research and development. Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
Tasks and responsibilities:
- Leads design, development of new products. Provides technical direction and solution for life cycle management of on- market products.
- Uses expertise in lateral flow technology to design and implement new methodologies, materials, processes and products. Demonstrates expertise and strong leadership in lateral flow product development. Designs and conducts studies in various phases of product lifecycle.
- Leads team, sets direction, mitigates risks, resolves issues to meet business needs.
- Maintains detailed documentation throughout all phases of research and development and plays key role in design transfer to manufacturing.
- Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
- Demonstrates commitment to the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies.
- Utilize risk management tools to eliminate or mitigate potential device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
- Carries out duties in compliance with established business policies.
• Requires a graduate degree (or equivalent), PhD in a scientific discipline is preferred
• Successful transfer and commercialization of on-market product(s)
• 8+ years related experience in diagnostic, lateral flow technologies.
• Working knowledge of federal and other regulations governing medical device assembly and design, e.g. GMP, QSR, ISO and CMDR.
• In depth knowledge of multiple technical engineering disciplines.
• Able to work with a variety of people on multiple tasks.
• Strong problem-solving and troubleshooting skills
• Strong verbal and written communication skills
• Organized and detail oriented
• Knowledge and ability to use MS Office and other manufacturing systems
• Ability to work in a team environment