Technical Analyst II/III

2 weeks ago

Boston, United States BioAgilytix Full time

In this role, you will perform validation studies through the analysis of biological samples. Our clients trust us to deliver excellence in data and bioanalysis, and this role is a bedrock within our project lifecycle. You will work on a wide variety of sample validations, including biologics, protein, peptides, small molecules, and/or biomarkers with a team of expert scientists. This role is also exposed to a range of analytical instrumentation and each project looks different than the previous one. At BioAgilytix, we don't limit you to only extracting samples - we train you to become a scientist.

The Technical Analyst II/III will perform responsibilities of a traditional lab analyst, peer reviewer, and new system implementation specialist. Tasks will encompass running assays, reviewing data, and devising and implementing solutions tailored for both short-term and long-term objectives. Playing a pivotal role in our project lifecycle, you'll conduct validation studies on a spectrum of biological samples, ranging from biologics and proteins to peptides, small molecules, and biomarkers, collaborating closely with a proficient team of scientists. With each project presenting unique challenges, you'll have the opportunity to engage with a diverse array of analytical instrumentation and methodologies.

Essential Responsibilities: Laboratory

    • Prepare worksheets with minimal supervision
    • Prepare plate maps
    • Serve as lead analyst on sample analysis projects
    • Troubleshoot assays
    • Compile/process data (make power export)
    • Prepare summary tables
    • Peer review raw data
    • Order reagents
    • Participate in assay development and validation
    • Responsible for accurate record keeping with regard to sponsor's samples, data, and reports (documentation according to GxP guidelines)
    >
Essential Responsibilities: Data Review & Documentation
    • Perform Quality Control (QC) technical and scientific and compliance review of data and documentation generated by the Bioanalytical Operations group in support of regulated studies (e.g. GLP, GMP) and non-regulated
    • Identify deviations, OOS and OOT associated with Bioanalytical Operations data as applicable
    • Issue QC review observations and work closely with the scientific staff to ensure data integrity
    • Collect metrics data used to monitor the QC reviews
    • Follow QCT SOPs
    • Responsible for second-level technical reviews of documents prior to review by the project manager (e.g., Bioanalytical Project Manager (BPM), Principal Investigator)
    • independently creating reports, plans, and submission documents in support of internal BioAgilytix projects
    • Extracts and formats data from multiple lab systems (e.g., LIMs, SoftMax, FACs) to generate reports
Essential Responsibilities: System Facilitator
    • Support system implementation and updates, such as Watson LIMS or automation; liaise with all parties to promote adoption of systems for increased efficiency
    • Creates and manages system Standard Operating Procedures (SOPs), as needed
    • Creates and manages validation documents in internal quality management systems
    • Responsible for troubleshooting and overseeing resolution of technical issues that arise from the use of the LIMS
    • Plans future workflow improvements including but not limited to the implementation of new processes and integration of new systems
Additional Responsibilities
    • Other duties as needed
Minimum Preferred Qualifications - Education/Experience ((Technical Analyst II):
    • Bachelor's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with more than two (2) years' experience in a scientific laboratory environment; or
    • Master's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with more than one (1) year experience in a scientific laboratory environment
    • Experience using Watson LIMS
Minimum Preferred Qualifications - Education/Experience ((Technical Analyst III):
    • Bachelor's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with more than four (4) years' experience in a scientific laboratory environment; or
    • Master's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with more than two (2) years' experience in a scientific laboratory environment; or
    • PhD in molecular biology, biochemistry, immunology, biotechnology, or related field with one (1) year experience in a scientific laboratory environment
    • Experience using Watson LIMS
Minimum Preferred Qualifications - Skills:
    • Ability to carry out routine tasks accurately, following strict methodology to carry out analysis, preparing samples and maintaining and operating standard laboratory equipment.
    • Demonstrated ability to use and troubleshoot Watson LIMS
    • Must work effectively within team to meet objectives under time constraints
    • Ability to take direction well and multi-task
    • Detail oriented and highly organized
    • Experience working in a GxP environment preferred
    • Excellent oral and written communication skills
    • Proficient in the use of MS Excel and Word
Supervision Received:
    • Frequent supervision and instructions
    • Infrequently exercises discretionary authority
Working Environment:
    • Primarily laboratory environment
    • Exposure to biological fluids with potential exposure to infectious organisms
    • Rare exposure to skin and lung irritants, toxic materials, and hazardous waste
    • Personal protective equipment required, such as protective eyewear, garments, and gloves
    • Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
Position Type and Expected Hours of Work
    • This is a full-time, on-site position
    • Some flexibility in hours is allowed, but the employee must be available during the "core" work hours as published in the BioAgilytix Employee Handbook
    • Occasional weekend, holiday, and evening work required

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