Full-Time

Medical Technologist

Posted on 9/5/2025

BioAgilytix

BioAgilytix

501-1,000 employees

Global bioanalytical testing for drug development

No salary listed

Boston, MA, USA

In Person

Category
Medical, Clinical & Veterinary (1)
Required Skills
Customer Service
Requirements
  • Bachelor’s degree in medical technology or related life science.
  • National certification as a Medical Technologist MT (ASCP) / MT (AAB) or Medical Laboratory Scientist (MLS) through the American Society for Clinical Pathology (ASCP) or equivalent
  • Not less than five (5) years’ experience of running high complexity assays.
  • Solid knowledge and application of CLIA, CAP, and CLEP regulations, standards, and guidelines.
Responsibilities
  • Performing HIPAA-compliant high complexity testing according to approved procedures and within established turnaround times.
  • Analyzing, reviewing, approving, and reporting test and quality control results according to established acceptance criteria and approved procedures. Maintaining paper and electronic records of test results.
  • Complying with quality assurance procedures, participating in proficiency testing and competency evaluation throughout the year.
  • Identifying problems which may adversely affect test performance, troubleshooting test systems and taking appropriate action when appropriate or as directed by Laboratory Management. Including proactively informing Customer Service of any issues which may cause late results.
  • Performing and documenting routine equipment use, maintenance, calibration as well as routine, scheduled, and unscheduled preventive maintenance.
  • Participating in method development and equipment qualification activities as directed by Laboratory Management.
  • Supporting audits, inspections, and assisting in responding to observations, if applicable.
  • Maintaining current knowledge of relevant regulations, standards, guidelines, and MT certification through continuing education.
  • Overseeing technical and logistical aspects of assigned assays and the work of other technologists on those assays. Training other technologists on tests and laboratory procedures.
  • Actively participating in project based and continuous improvement work and other duties as needed.
Desired Qualifications
  • Ability to work in a fast-paced environment, where multiple concurrent projects must be completed in a timely manner remaining flexible, proactive, resourceful, and efficient with a high level of professionalism.
  • Strong hands-on laboratory skills: low volume pipetting in 96-well plates, confident and competent user of state-of-the-art laboratory instrumentation.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Acute attention to detail and excellent organizational, and communication skills, highly computer literate.

BioAgilytix is a global bioanalytical laboratory that provides testing services for pharmaceutical, biotechnology, and agricultural biotech companies, with a notable presence in Hamburg, Europe. It specializes in large-molecule studies and runs assays such as pharmacokinetics, pharmacodynamics, cell-based tests, and immunogenicity to measure how drugs behave in the body and assess safety and efficacy. The company offers customizable, service-based testing that supports drug development from research through regulatory approval, including COVID-19 testing packages. Its differentiators are its global reach, deep expertise in large-molecule workflows, and a flexible model that partners with clients on a project basis. Its goal is to deliver precise, validated bioanalytical data that helps clients develop and bring new therapies to market.

Company Size

501-1,000

Company Stage

Growth Equity (Venture Capital)

Total Funding

$30.1M

Headquarters

Durham, North Carolina

Founded

2008

Simplify Jobs

Simplify's Take

What believers are saying

  • Gene therapy market expansion as anti-AAV assay addresses rare disease diagnostics.
  • European market growth through Hamburg lab qPCR expansion and leadership hires.
  • Strategic partnerships with BBI Solutions and A3P Biomedical diversify revenue streams.

What critics are saying

  • Cancelled $61.5M Durham expansion forfeits 878 jobs, damaging talent acquisition capacity.
  • Charles River and Labcorp undercut pricing via integrated CRO scale advantages.
  • Eurofins AI-optimized assays deliver 40% faster turnaround, threatening biotech client retention.

What makes BioAgilytix unique

  • FDA Breakthrough Device Designation for anti-AAV antibody assay supporting gene therapy.
  • Global laboratory network across US, Australia, Germany enabling early-phase to market authorization.
  • Specialized expertise in large molecule bioanalysis, immunogenicity, and cell-based assays.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Company Match

Parental Leave

Employee Referral Bonus

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

0%

2 year growth

18%
The Associated Press
Feb 10th, 2026
BioAgilytix receives FDA breakthrough device designation for anti-AAV antibody assay supporting gene therapy

BioAgilytix Labs has received FDA Breakthrough Device Designation for its anti-AAV antibody assay supporting Lexeo Therapeutics' gene therapy programme for Friedreich ataxia cardiomyopathy, a rare progressive disorder affecting approximately 15,000 people worldwide. The plate-based MSD anti-adeno-associated virus serotype rh.10 total antibody assay enables precise patient selection and monitoring for gene therapy programmes. The FDA's Breakthrough Device Designation expedites development and review of novel medical devices treating life-threatening or irreversibly debilitating conditions. BioAgilytix is among a limited number of contract research organisations to receive breakthrough designation for a diagnostic assay supporting an investigational device exemption. The Durham, North Carolina-based company operates laboratories across the US, Australia and Germany, providing bioanalytical testing services for pharmaceutical and biotechnology organisations.

Rapid Test Methods Ltd
Jun 18th, 2024
BBI and BioAgilytix Partner to Streamline and Simplify Bioanalytical Testing

BBI Solutions OEM Limited (BBI), a trusted expert provider of end-to-end solutions for the development of high-performance assays, has signed a partnership agreement with BioAgilytix, a leading global bioanalytical laboratory.

The Business Journals
Mar 26th, 2024
Durham firm cancels deal that promised 878 jobs

BioAgilytix in 2020 picked the Triangle over competing sites in Massachusetts for a $61.5 million expansion that was expected to add 878 local jobs.

360Dx
Sep 13th, 2023
A3P Biomedical, BioAgilytix Partner to Bring Prostate Cancer Test to US

NEW YORK - Swedish diagnostics firm A3P Biomedical announced on Wednesday that it has partnered with BioAgilytix to bring A3P's prostate cancer test to the US as a laboratory-developed test.

A3P Biomedical
Sep 13th, 2023
A3P Biomedical and BioAgilytix enter partnership for Stockholm3 in the USA

Recognizing the critical need for improved prostate cancer diagnostics, A3P Biomedical and BioAgilytix have joined forces to introduce Stockholm3 as a novel LDT in the US market.

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