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Scientist I

San Diego, CA 92121

Posted: 01/24/2023 Employment Type: Contract Job Category: Scientific Job Number: 536895 Is job remote?: No Country: United States

Job Description

Target PR: 35-37/hr
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.

RESPONSIBILITIES:
 
  • 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

PREFERRED QUALIFICATIONS:
  • 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

COMPETENCIES:
  • Teamwork
  • Initiative
  • Self-starter
  • Driven for results
  • Communication
  • Able to shift priorities and adapt to new responsibilities within a fast-paced environment
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