9940 Mesa Rim Rd San Diego, CA 92121 US
The scope of this position is responsible for DOA production development and research within the R&D Department.
This job description will be reviewed periodically and is subject to change by management.
- 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, and may create and develop new methods and technologies for project advancement with guidance from more experienced colleague.
- Possesses and applies knowledge of principles, practices, and procedures of particular field of specialization to the completion of moderately complex assignments.
- Works on problems of moderate and diverse scope in which analysis of data requires evaluation of identifiable factors. Proposes potential solutions to more advance problems.
- Conducts experiments of more complex projects, seeks advice when needed from more experienced colleagues for more complicated technical and design challenges. able to handle multiple projects independently.
- Determine methods and procedures on new assignments and provides guidance to junior personnel.
- May direct less experienced RAs in their day to day work and assist in problem solving.
- 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 minimal guidance. order materials needed to complete procedures.
- 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
MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:
- BS degree in chemistry sciences or biological science field with 7 + years of progressively responsible positions particularly in lateral flow assay research development environment; MS or Ph.D. strongly preferred.
- 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 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
- Driven for results
- Able to shift priorities and adapt to new responsibilities within a fast-paced environment
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.