Job Description

Position Summary:

The Technical Operations, Sr Lab Technician will support the Technical Operations Team in an in vitro medical diagnostics device manufacturing setting. The technician will execute experiments to facilitate investigations, problem solving and disposition of manufactured products. Additional duties include laboratory maintenance, documentation, organization, equipment maintenance, and ordering supplies.

Key Responsibilities:

* Execute experiments to aid in investigations of nonconformances
* Execute experiments related to in-process assay development
* Maintain laboratory notebook per company policy
* Assist in writing validation protocols as well as coordinating validation processes
* Assist in data tracking and trending
* Write standard operating procedures, reports, work instructions
* Must be able to verbally communicate clearly and provide progress updates and data summaries
* Work with scientists to understand and align investigation goals
* Follow experimental protocols, and identify/communicate issues to team
* Effectively communicate and interface with other teams to ensure timely completion of investigations, resolutions, and disposition of products
* Additional duties as assigned

Minimum Requirements/Qualifications:

* Bachelor2019s degree in Chemistry/Material Science/Biochemistry/ Molecular Biology/Biology
* 1-3 years of laboratory experience
* Candidates who are undergraduates in their senior year (or equivalent) will be considered provided they have at least 2 years of laboratory experience in industry or academic settings and have the required knowledge and skills
* Hands-on experience in molecular biology techniques (PCR, RT-PCR), aseptic technique, buffer preparation
* Experience in nucleic acid handling (quantification, purification, extraction)
* Experience working in a regulated environment (FDA/GMP/ISO) is preferred
* Experience in completing documentation and data collection in a GMP laboratory is preferred
* Experience working with a broad set of laboratory instruments (plate readers, pH meter, analytical balance, spectrophotometer, PCR machine, lyophilizes, mass spectrometry, or chromatography systems) is preferred
* Experience in the medical device and/or biotechnology industry is preferred

Personal attributes:

* Understands good laboratory practices and good manufacturing practices
* Hands-on experience in buffer preparation and general laboratory techniques (dilutions, measurements, pipetting and has ability to use general laboratory instruments (pH meter, scale, centrifuge)
* Has ability to perform general molecular biology techniques (PCR, qPCR, electrophoresis, oligo quantification)
* Strong written and oral communication skills
* Ability to multitask and complete projects in a fast-paced environment
* Must be self-motivated, detail-oriented, organized and have ability to work in a team environment.
* Must be well versed in MS Office Applications, particularly Excel and PowerPoint