Scientist II - R&D - Lateral Flow Assay Development (31019284)
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.
Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
The position of Scientist II is within our Toxicology business unit located in San Diego, California. The scope of this position is responsible for expansion of lateral flow assay development for drugs of abuse and on market support of existing eCup Plus.
WHAT YOU’LL DO
Executes and conducts research; may develop or recommend new procedures related to R&D processes.
Uses advanced professional concepts to contribute to the development of company concepts and principles and to achieve objectives in creative and effective ways.
Investigates, creates and develops new methods and technologies for project advancement with limited assistance.
Exercises good judgment on details of work when less common or proposed methods or procedures are necessary. Is expected to detect problems in using standardization procedures because of the condition of the sample, difficulties with the equipment, etc.
Works on moderate to more complicated or compound problems in which analysis of situations or data requires evaluation of identifiable factors from multiple disciplines; Proposes more throughout potential solutions to advanced problems based on experience.
Conducts experiments of more complex problems, seeks advice from more experienced colleagues for more complex/advanced scientific challenges.
Determine methods and procedures on new assignments and provides guidance to junior personnel.
May plan and work on projects of moderate complexity under limited to no supervision
May direct less experienced RAs in their day to day work and assist in problem solving.
May have supervisor duties for small teams may direct less experienced RAs in their day to day work and assist in problem solving. May be involved in interviewing, training employees; planning, assigning, and directing work and resolving technical problems
Provides sound and original suggestions for new problems.
Perform analytical test methods on the finished products based on CLSI and other FDA guidelines
Participate as an integral member of the scientific staff in research strategy and methodology to resolve issues
Provide recommendations and observations to scientific staff and management on results of projects/tasks. Play a key role in the research strategies and tactics for new or existing R&D projects.
May conduct interviewing, training employees, planning, assigning, directing work and resolving technical problems.
Maintain records of laboratory activities and notebooks in a professional, accurate manner. May provide support to regulatory and intellectual property activities.
Transfer developed processes to the Manufacturing Team. Write and revise process document reports and transfer protocols.
Ability to create, review, and work with SOPs, MPs, and Batch Records
Operate complex laboratory equipment and perform routine maintenance and repair. Interface with contracted repair technicians as required. Understand theoretical basis for analytical instrumentation.
Functionally direct junior research staff, as required.
Initiate literature review and searches to support ongoing research activities. Summarize findings in final form to management and recommend follow-up actions.
Generate oral and written reports and to summarize laboratory activities and projects per R&D manger’s request. Initiate communication with R&D manager and functions as necessary to coordinate other staffs’ activities effectively.
Monitor and maintain necessary laboratory supplies, with approval by senior department staff or R&D manager
Write verification and validation protocols and reports with minimum or no guidance. order materials needed to complete procedures as needed.
Work involving urine, blood or other potentially infectious materials may be required
Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships
Carries out duties in compliance with established business policies
Other duties as assigned, according to the changing needs of the business
EDUCATION AND EXPERIENCE YOU’LL BRING
BS degree in chemistry sciences or biological science field with 5 + years of progressively responsible positions in a research development environment; MS or Ph.D. strongly referred.
Experience with multiple immunoassay platforms and technologies
Ability to functionally direct and train junior research staff
Ability to work well with global teams, including time-zone flexibility
Excellent presentation, oral and written communication skills, computer skills with MS Word, Excel, PowerPoint, JMP, and other statistical programs
Operate complex laboratory equipment and perform routine maintenance
Ability to communicate and work with external and internal Abbott Rapid Diagnostic development partners, resource planning and management of time across multiple projects
Experience with lateral flow assays and/or liquid assays in drugs of abuse highly desired
Hands-on experience developing assays to semi-quantitative or qualitative drug levels, anti-drug antibodies, and pharmacodynamic measures of activity using immunoassays and/or other methodologies
Experience interpreting and reporting complex immunogenicity data
Experience in Quality Assurance, i.e. CAPA, quality incidents
Process orientated, logical, analytical, meticulous, highly organized and able to analyze data and implement solutions
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
Training and career development, with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: [Register to View]
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.