Part-Time
Technical Writer
Multiple Teams
Posted on 9/29/2025
BioAgilytix
501-1,000 employees
Global bioanalytical testing for drug development
No salary listed
Melbourne VIC, Australia
In Person
This role is offered on a casual basis, ideally across 3–4 days per week.
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- Bachelor of Science (Hons) or equivalent qualification plus relevant experience
- Experience in medical laboratory techniques
- Excellent organisational and writing skills
- Ability to work as part of a team
- Good communication skills
- Proficient in use of Word Office, including Word, Excel, and PowerPoint
- Experience with database software and file management
- Maintain high levels of communication with colleagues and maintain productive relationships with clients, CROs, collaborators and partners
- Adhere to ISO/IEC 17025, the OECD Principles of Good Laboratory practice, 360biolabs’ Quality Management System, SOPs, and other requirements as per NATA Accreditation and regulatory guidelines
- Maintain awareness of, and ensure compliance with, relevant International Standards and Guidelines including ICH GCP
- Liaise with colleagues to ensure study activities are delivered consistent with Work Order timelines
- Maintain records to levels consistent with relevant standards
- Prepare and review reports related to assay validation, assay qualification, assay qualification, laboratory manuals, analytical protocols and study reports
- Perform data analysis and provide clear interpretation of data to others
- Produce reports for internal use and communication to clients
- Attend meetings associated with clinical research and the work of 360biolabs
- Participate in professional activities including attendance at training courses and seminars as required
- PhD in a Biological discipline or equivalent experience
- Experience in the conduct of clinical trials
- High motivation and enthusiasm for medical research and drug development
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'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
6 month growth
↑ 0%1 year growth
↑ 0%2 year growth
↑ 18%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.
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.
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.
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.
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.