Associate Biologist

TÜV SÜD America Hiring for Associate Biologist for New Brighton, MN Location.

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Title: Associate Biologist

Duration: Full Time Employment

Location: New Brighton, MN

Job Title:

Medical Device Biocompatibility – Associate Biologist

Overview:

Looking for a knowledgeable associate biologist who enjoys working in a fast-paced environment. The candidate will perform laboratory-based in vitro biocompatibility studies evaluating a variety of medical devices for cytotoxicity, genotoxicity, and hemocompatibility according to ISO 10993, ASTM, OECD, USP, and JMHLW guidelines. The ideal candidate has a good laboratory background in medical device testing, as well as excellent attention to detail and problem-solving skills.

Responsibilities:

• Performs studies in accordance with Good Laboratory Practice (GLP) and assures that all applicable regulations are followed
• Provides scientific support to the Team Lead and other scientific staff in the study design, conduct, and interpretation of test assays to ensure technical integrity of studies
• Assures adherence to protocol, protocol amendments, and company SOPs throughout the conduct of studies
• Assures that all data including unanticipated responses are accurately recorded, verified, and organized
• Utilize strong time management skills to efficiently perform and analyze multiple studies while adhering to study timelines
• Collaborate and clearly communicate with Team Lead to ensure client's needs are met
• Assist with performing cell production, lab inventory, and test sample and reagent preparation according to work instructions
• Maintain ancillary records (logbooks, worksheets) according to protocols, SOPs, and GLP regulations
• Perform the extraction process on prepared samples in accordance with federal and international regulations as directed by study protocol for biocompatibility assays
• Perform daily, weekly, and monthly cleaning, maintenance, and monitoring of equipment and lab spaces
• Perform support tasks such as obtaining proper documentation for laboratory supplies, receiving supplies, preparing and maintaining sterile glassware via processes of washing, autoclaving, and depyrogenation
• Participate in the improvement of documents, test systems, quality systems, and workflow
• Other duties as assigned by management
• Weekend work is possible

Qualifications:

• Minimum BS/BA in biology or related field
• Minimum of 1-2 years of applicable experience in a laboratory environment with knowledge of medical device testing for assessment of cytotoxicity, hemocompatibility, and genotoxicity
• Working knowledge of industry regulations supporting a medical device environment
• Strong communication skills
• Ability to organize and perform multiple projects in a detail-oriented manner with minimal assistance
• Maintain accurate schedule and follow-up efficiently
• Strong organizational and problem-solving skills
• Proactive, collaborative team player
• Self-starter with a positive and motivated attitude

Working Conditions:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The employee is regularly exposed to sharps, human and animal blood, and hazardous or caustic chemicals. The noise level in the work environment is usually moderate. Safety glasses are required in the laboratory.
• The employee is regularly required to stand, walk, use hands, talk, and hear. The employee is occasionally required to crouch, bend, twist, and reach. The employee is occasionally required to lift and/or move up to 50 pounds and lift and/or move up to 75 pounds with assistance. The employee may be required to view computer monitors and stand for extended periods of time.
• Specific vision abilities required by this job include close vision, the ability to adjust focus, distinguish color, exceptional spatial acuity, and visual-kinesthetic coordination.