Abbott Scientist II in California
At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 160 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.
The position of Scientist II is within our Toxicology business unit located in Pomona, California. The scope of this position is responsible for implementing the Quality System integration for R&D. This will be a key role in Assay Development Team within the R&D Department.
This job description will be reviewed periodically and is subject to change by management.
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 the workplace, healthcare providers, and individuals.
Thisposition will be the lead Scientist in the R&D department to implement theQuality System integration efforts for new and existing products
Mustbe proficient in Design Control process
Designexperiments based on deliverables and plan activities to meet the projecttimelines
Conductcomplex experimentation including data collection, summary and thoroughanalysis, in support of department research projects and guidelines. Composerobust experimentationstrategies that maximize effective use of resources and time to deliver optimuminformation.
Performanalytical test methods on the finished products based on CLSI and other FDAguidelines
Participateas an integral member of the scientific staff in research strategy andmethodology to resolve issues
Providerecommendations and observations to scientific staff and management on resultsof projects/tasks. Play a key role in the research strategies and tacticsfor new or existing R&D projects.
Innovateresearch methods and product formulation to resolve problems and accomplishcompany objectives. Pro-actively recommend strategy to overcome hurdles.
Maintainrecords of laboratory activities and notebooks in a professional, accuratemanner. May provide support to regulatory and intellectual propertyactivities.
Transferdeveloped processes to the Manufacturing Team. Write and revise processdocument reports and transfer protocols.
Abilityto create, review, and work with SOPs, MPs, and Batch Records
Operatecomplex laboratory equipment and perform routine maintenance and repair.Interface with contracted repair technicians as required. Understandtheoretical basis for analytical instrumentation.
Mayfunctionally direct junior research staff, as required
Initiateliterature review and searches to support ongoing research activities.Summarize findings in final form to management and recommend follow-up actions.
Generateoral and written reports and to summarize laboratory activities and projectsper R&D manger’s request. Initiate communication with R&D managerand functions as necessary to coordinate other staffs’ activities effectively.
Monitorand maintain necessary laboratory supplies, with approval by senior departmentstaff or R&D manager
Workinvolving urine, blood or other potentially infectious materials may berequired
Knowledgeableof federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR
Understandsand is aware of the quality consequences which may occur from the improperperformance of their specific job; has awareness of device defects that mayoccur in their area of responsibility, including product design, verificationand validation, manufacturing and testing activities
Responsiblefor exhibiting professional behavior with both internal/external businessassociates that reflects positively on the company and is consistent with thecompany’s policies and practices; build productive internal/externalworking relationships
Carries outduties in compliance with established business policies
Otherduties as assigned, according to the changing needs of the business
MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:
A minimum ofBS degree with at least 8-10 years of experience OR MS degree with atleast 4 years of experience OR PhD degree with at least 3 years ofexperience in immunoassay/IVD development
Experiencewith multiple immunoassay platforms and technologies
Ability totravel minimally if necessary
Strong experience in Design Control process
Hands-on experience developing assays to semi-quantitative orqualitative drug levels, anti-drug antibodies, and pharmacodynamic measures ofactivity using immunoassays and/or other methodologies
Experience interpreting and reportingcomplex immunogenicity data
Experience in Quality Assurance, i.e. CAPA, quality incidents
Cross-functional experience is strongly
Process orientated, logical, analytical, meticulous, highlyorganized and able to analyze data and implement solutions
Operate complex laboratory equipment and perform routinemaintenance
Ability to communicate and work with external and internal AbbottRapid Diagnostic development partners, resource planning and management of timeacross multiple projects
Ability to functionally direct and train junior research staff
Ability to work well with global teams, including time-zoneflexibility
Excellent presentation, oral and written communication skills,computer skills with MS Word, Excel, PowerPoint, JMP, and other statisticalprograms
Driven for results
Able to shift priorities and adaptto new responsibilities within a fast-paced environment
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 130 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 107,000 of us are working to help people live not just longer, but better, in the more than 160 countries we serve.
An equal opportunity employer, Abbott welcomes and encouragesdiversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please send an email to email@example.com .
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org