Research Scientist II

1 week ago

South Portland, Maine, United States ATR International Full time

Job Description:

We are seeking a Research Scientist II for a very important client.

We have an exciting opportunity for a Research Scientist II, focused on technical documentation, within the Research & Development team at our Client's Rapid Diagnostics business located at Scarborough, ME. In this role, you will help support on market products for the BinaxNOWTM and ID NOWTM platforms by supporting the development and creation of high-quality written content for internal and external audiences.

Rapid Diagnostics is part of Client'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.

RESPONSIBILITIES

· Participate in a Quality Management Systems Program, with the primary responsibility being the creation of high-quality written content to support regulatory submissions.

· Daily interaction with technical documentation, documentation tasks to be performed with high-throughput and attention to detail

· Required to proofread, prepare, create, review, edit, and/or update Quality and Technical Documents including, but not limited to: SOPs, Design Control Documentation (Design and Development Plan, Customer Requirements, Product Requirements, Design Outputs, Design Verification Protocol and Reports), Technical Reports, Risk Management Documentation including FMEAs

· Understands and is aware of the quality consequences which may occur from the improper product performance; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing, and testing activities

· Plans and works on projects of moderate complexity under limited to no supervision

· May have supervisor duties for small teams and may direct staff in their day to day work and assist in problem solving.

· Demonstrate technical proficiency in general laboratory techniques

· Conduct experiments of a varied nature in support of on-market products

· Works with multidisciplinary team including other scientists, researchers, and technicians.

· Analyze experimental results and provide written reports and oral presentations to executives

· 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

· Adapt rapidly to a changing industry and be able to adjust responsibilities, time and objectives accordingly

· Perform other duties & projects as assigned

BASIC QUALIFICATIONS

· Bachelor's degree in Biology, Biochemistry or Chemistry, or related technical field

· Minimum of 5+ years of progressively responsible positions in a research development environment with laboratory and technical writing experience working under design control and developing human in vitro diagnostic tests for commercialization in the U.S and OUS

· Ability to work as part of a team with excellent communication skills

· Problem-solving skills combined with analytical skills and attention to detail

· Experience owning the end-to-end documentation creating process

· Proficiency with Microsoft Office, specifically in Word, Excel, and PowerPoint

· Must be able to productively generate quality documentation to meet program timelines

COMPETENCIES

· Project planning

· Team leadership

· Comprehension of scientific literature and terminology

· Practical laboratory skills

· Ability in mathematics and computer literacy

· Good communication skills, capable of communicating ideas to colleagues and customers

· Problem–solving skills and good organizational skills

· Understanding of the commercial value of their work

· Firm knowledge of science and the ability to apply basic principles and techniques.

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