At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.

BioAgilytix is growing our Project Management team, and we have multiple openings across the Project Manager and Senior Project Manager levels within Operations.

These roles are central to the successful delivery of our client programs, serving as a key connection point between our clients and internal scientific and operational teams. You will partner closely with stakeholders across Operations, Quality Control, Quality Assurance, Sample Management, Finance, Proposals, and other functions to keep programs aligned, risks visible, and deliverables moving forward.

We are hiring at both the Project Manager and Senior Project Manager levels, with level determined based on experience, demonstrated project ownership, and the complexity of programs a candidate is prepared to lead.

At the Project Manager level, the focus is on coordinating stakeholders and successfully managing intermediate-level projects or project segments. At the Senior Project Manager level, the role expands to independent, end-to-end ownership of higher-complexity programs, multiple concurrent projects, and more proactive client, risk, and escalation management.

What You'll Do

Across both levels, you will:

Serve as a key point of coordination between clients and internal project stakeholders.
Build strong working relationships across Operations, Quality Control, Quality Assurance, Sample Management, and other supporting functions.
Coordinate project timelines, deliverables, milestones, and stakeholder activities.
Facilitate client and project team meetings, including agendas, meeting minutes, decisions, and action items.
Monitor revenue recognition and project milestones using financial systems; NetSuite experience is preferred.
Identify challenges that could impact successful program delivery and work cross-functionally to resolve them.
Support identification and execution of contract amendments in partnership with the Proposals team.
Utilize project management tools to organize work, increase visibility, and foster effective collaboration.
Adapt to changing project requirements while maintaining focus on client needs and program delivery.

Project Manager — What You'll Own

As a Project Manager, you will focus on the successful coordination and management of intermediate-level projects or project segments while continuing to develop your ability to independently manage increasingly complex client programs.

You will:

Coordinate project elements and stakeholders to support successful delivery.
Manage intermediate-level project segments and associated deliverables.
Support routine client teleconferences and formalize decisions and actions through agendas and meeting minutes.
Monitor project activities and help address issues that could impact program delivery.
Support the identification and coordination of contract amendments.
Apply project management tools and processes to improve task management and team collaboration.
Work with regular guidance while building greater autonomy and decision-making responsibility.

Project Manager Minimum Preferred Qualifications:

Bachelor's degree in life science or related field with 4+ years of experience in biotechnology project management or a related field; OR
Master's degree in life science or related field with 2+ years of relevant experience.
Scientific knowledge and familiarity with regulations relevant to the CRO industry.
Knowledge of project management software; Smartsheet experience preferred.
Effective written and verbal communication skills with the ability to interact successfully with clients and internal stakeholders.
Strong attention to detail with developing organizational and project administration skills.
Proficiency in Microsoft Office, including Word, Excel, and Outlook.

Senior Project Manager — What You'll Own

As a Senior Project Manager, you will operate with greater independence and take end-to-end ownership of higher-complexity client programs and multiple concurrent projects.

In addition to the responsibilities above, you will:

Act as the client's internal advocate, driving effective cross-site communication, transparency, and alignment.
Lead higher-complexity and multiple concurrent projects from initiation through closeout.
Maintain alignment between project execution, strategic goals, budget, scope, and forecasted timelines.
Lead routine client teleconferences and drive decisions, actions, and follow-through.
Define and monitor project timelines in partnership with internal and external stakeholders.
Proactively identify project risks, barriers, and potential delivery issues and drive resolution through defined escalation pathways.
Proactively identify required contract amendments and coordinate them from identification through execution.
Support program-level dashboards and KPIs that provide visibility into project risk and governance.
Exercise significant independent judgment and discretionary authority in managing assigned programs.

Senior Project Manager Minimum Preferred Qualifications:

Bachelor's degree in life science or related field with 6+ years of experience in biotechnology project management or a related field; OR
Master's degree in life science or related field with 4+ years of relevant experience.
Scientific knowledge and familiarity with regulations relevant to the CRO environment, with experience in biotechnology, pharmaceutical, CRO/CMO, or a similar industry preferred.
High proficiency with project management software; Smartsheet experience preferred.
Project Management Professional (PMP) certification preferred.
Excellent written and verbal communication skills with demonstrated ability to successfully manage key client and internal stakeholder relationships.
Strong organizational and project administration capabilities with the ability to coordinate multiple projects and priorities under time constraints.
Ability to work independently with limited supervision and exercise sound judgment in complex project situations.

How We Determine Level

Candidates will be considered for the level that best aligns with their experience and demonstrated capabilities.

Project Manager candidates will typically bring experience coordinating and managing defined projects or project segments, partnering effectively with stakeholders, and solving project delivery challenges with regular guidance.

Senior Project Manager candidates will demonstrate a track record of independently owning complex client programs, managing multiple concurrent projects, proactively identifying and escalating risk, and driving cross-functional stakeholders toward successful project delivery.

Supervisory Responsibilities

This position has no supervisory responsibilities.

Supervision Received

Infrequent supervision and instructions
Frequently exercises discretionary authority

Working Environment

Primarily office environment. Full-time in office attendance is required to support project coordination and team collaboration
Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets

Physical Demands

Ability to work in an upright and/or stationary position for up to eight (8) hours per day
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate office equipment
Ability to access and use a variety of computer software
Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
Frequently interacts with others to obtain or relate information to diverse groups
Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals; requires multiple periods of intense concentration
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
Ability to perform under stress and multi-task
Regular and consistent attendance

Position Type and Expected Hours of Work

This is a full-time site-based role.
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

BENEFITS AND OTHER PERKS

Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (9 scheduled; 5 floating), 401k with Employer Match, Employee Referral Program

COMMITMENT TO EQUAL OPPORTUNITY

BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.

To learn more about how we collect, use, and protect your information, please review our Privacy Policy and Terms of Use.

About the company

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

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Simplify's Take

What believers are saying

Lexeo’s February 2026 gene-therapy program elevates BioAgilytix into premium regulatory work.
May 2026 Morrisville GMP expansion increases capacity for higher-margin QC testing.
Hamburg regained French CIR approval in 2026, supporting European commercial credibility.

What critics are saying

BioAgilytix sued ex-executive James McNally in April 2025 over trade secrets.
Revelio shows 2026 active postings fell 46.8%, signaling slower hiring momentum.
Heavy private-equity ownership from Cinven and Cobepa pressures margin expansion and exit timing.

What makes BioAgilytix unique

FDA granted BioAgilytix Breakthrough Device Designation for AAVrh.10 assay in February 2026.
BioAgilytix runs 355,000 square feet across Durham, Hamburg, and Australia.
Its 2025-2026 LC/MS investments strengthened global bioanalysis and CMC analytical services.

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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

Growth & Insights and Company News

6 month growth

1 year growth

2 year growth

Ochre Digi Media Pvt. Ltd.

Oct 13th, 2026

BioAgilytix expands global bioanalytical capabilities with new Sydney laboratory.

BioAgilytix expands global bioanalytical capabilities with new Sydney laboratory. Tuesday, October 13, 2026 BioAgilytix, a global leader in bioanalytical services, announces the opening of a new laboratory in North Ryde, Sydney, through 360biolabs, its Australian laboratory business. The expansion extends BioAgilytix's bioanalytical footprint across Australia, Europe and the United States. The laboratory is located in Sydney's Macquarie Park Innovation District, a major New South Wales science, health and technology precinct near clinical trial units, hospitals, research organizations and participant populations. With locations in Melbourne, Brisbane and Sydney, 360biolabs gives sponsors access to bioanalytical support across Australia's eastern states, where much of the country's clinical research infrastructure and population base is concentrated. The Sydney laboratory has been purpose-built for time-sensitive clinical trial samples and complex early-phase study requirements. Initial capabilities in the BSL-2 laboratory space include PBMC isolation, flow cytometry, sample reception and storage, ULT freezer capacity, vapour-phase nitrogen cryostorage, and 24/7 temperature monitoring. For sponsors planning first-in-human and early clinical studies, the expansion supports a practical development model: generate early data in Australia, then maintain scientific and operational continuity as programs advance into later-phase global development. "Australia is a primary destination for early-phase clinical research, supported by a streamlined regulatory pathway, rapid study start-up timelines and R&D tax incentives for eligible sponsors," said Davide Molho, CEO of BioAgilytix. "The new Sydney laboratory expands BioAgilytix's Australian footprint through 360biolabs, alongside Melbourne and Brisbane, and strengthens our ability to support sponsors as their programs advance across global regions." Australia can support efficient early-phase clinical study execution through its recognised quality standards, practical regulatory environment, cost efficiency for eligible sponsors and data utility when studies are conducted to accepted requirements. The Sydney expansion reinforces BioAgilytix's ability to support sponsors seeking a coordinated pathway from first-in-human studies through global development. "Sydney allows us to invest alongside the growth in Australia's clinical trials infrastructure. It expands our ability to support clients locally, strengthens our national business and creates a stronger foundation for continued growth in the region." said Alistair Draffan, President of 360biolabs. 360biolabs is accredited by Australia's National Association of Testing Authorities (NATA) for compliance with Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), and ISO/IEC 17025. This accreditation supports sponsors seeking recognised quality standards for early-phase studies conducted in Australia. The Sydney laboratory extends BioAgilytix's global network and strengthens its ability to support sponsors with local expertise and continuity across regions as programs progress. About 360biolabs 360biolabs is Australia's most comprehensive bioanalytical laboratory, supporting the development of therapeutics, vaccines and diagnostics. With laboratories in Melbourne, Brisbane and Sydney, 360biolabs supports clinical studies across PK, PD, immunogenicity, biomarkers, vaccines, infectious diseases, flow cytometry, molecular biology and central laboratory services. 360biolabs is accredited by Australia's National Association of Testing Authorities (NATA) for compliance with Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), and ISO/IEC 17025. About BioAgilytix BioAgilytix is a global bioanalytical laboratory partner supporting biopharmaceutical and biotechnology companies across every phase, every modality. Through its global laboratory network in Australia, the United States and Europe, BioAgilytix provides integrated scientific and operational support for complex clinical development programs. Media Contact Bernice Averion Marketing and Communications Manager, 360biolabs [email protected]

BioAgilytix

Mar 24th, 2026

BioAgilytix celebrates Jessica Bridges Weaver for scientific leadership with 2026 TBJ Award.

BioAgilytix celebrates Jessica Bridges Weaver for scientific leadership with 2026 TBJ Award. Durham, N.C. - March 24, 2026 - BioAgilytix, a global leader in bioanalytical services, is proud to celebrate its commitment to scientific excellence and leadership with Jessica Bridges Weaver, Scientific Officer, who has been named a 2026 Triangle Business Journal Women in Business Award Winner. With more than 20 years of experience across pharmaceutical manufacturing and analytical testing, Jessica has played a critical role in strengthening BioAgilytix's scientific and regulatory leadership. In her role, she partners closely with global laboratory and business development teams to advise clients on phase-appropriate, regulatory-ready testing strategies for complex biologics. Her work extends to assay design and troubleshooting, ensuring methods align with both client objectives and evolving global regulatory expectations. Her impact has been especially evident in the strategic expansion of BioAgilytix's CMC analytical testing services in the Research Triangle Park hub, as well as the global growth of GMP bioassay capabilities and the development of specialized infrastructure in Hamburg, Germany. Beyond operational leadership, Jessica is a recognized thought leader in CMC analytics and bioanalysis who produces and delivers webinars, conference presentations, and peer-reviewed publications that promote continuous learning and knowledge-sharing across the life sciences community. "Jessica exemplifies the scientific rigor, integrity, and collaborative leadership that defines BioAgilytix," said Davide Molho, Chief Executive Officer of BioAgilytix. "Her ability to translate complex science into meaningful impact for our clients and the industry makes her an outstanding leader and a deserving recipient of this recognition." In addition to her professional achievements, Jessica is deeply committed to community service and mentorship. She actively supports STEM education initiatives, mentors high school students, and partners with organizations focused on pediatric care and child welfare. Her work reflects a lifelong commitment to stewardship, integrity, and expanding access to opportunities for future generations. "It is truly an honor to be recognized alongside so many inspiring women," said Jessica Weaver. "This recognition reflects the incredible teams I am privileged to work with at BioAgilytix and our shared commitment to advancing science, strengthening communities, and improving patients' lives. I am grateful for the opportunity to contribute to work that creates meaningful impact for our clients and the broader life sciences community." Jessica's recognition represents the strength of the BioAgilytix community, and a culture built on collaboration, integrity, and scientific excellence. About BioAgilytix BioAgilytix is the trusted partner for bioanalytical services throughout every phase of the drug development process. As a leading global bioanalytical laboratory, the company provides established and emerging pharmaceutical and biotechnology organizations with pharmacokinetic (PK), immunogenicity, biomarker, and CMC analytical testing services in a GxP environment. BioAgilytix maintains state-of-the-art laboratories in Durham, North Carolina; Boston, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia; and Hamburg, Germany. For more information, please visit www.bioagilytix.com.

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.