Full-Time

Manager 2

LC/MS Bioanalytical

Posted on 2/11/2026

BioAgilytix

BioAgilytix

501-1,000 employees

Global bioanalytical testing for drug development

Compensation Overview

$160k - $175k/yr

San Diego, CA, USA

In Person

Category
Biology & Biotech (2)
,
Required Skills
Word/Pages/Docs
Data Analysis
Excel/Numbers/Sheets
Requirements
  • Bachelor’s degree in chemistry, biochemistry, biotechnology, or related field with not less than twelve (12) years’ experience in a scientific laboratory environment; or Master’s degree in chemistry, biochemistry, biotechnology, or related field with not less than ten (10) years’ experience in a scientific laboratory environment; or PhD in chemistry, biochemistry, biotechnology, or related field with not less than eight (8) years’ experience in a scientific laboratory environment
  • Ability to develop chromatographic assays for all modalities in complex biological matrices using HPLC or LC/MS/MS and oversee the following study types: regulated bioanalysis, tissue analysis, protein binding, CYP inhibition, CYP induction, CYP phenotyping or metabolite profiling/ID
  • Write and execute validation and sample analysis plans
  • Review and evaluate PK/TK data and ISR results to identify trends and outliers
  • Plan and execute cross-site validations for projects transferring between sites
  • Must work effectively within team to meet objectives under time constraints
  • Ability to make sound judgments quickly and confidently
  • Ability to take direction well and multi-task
  • Detail oriented and highly organized
  • Excellent oral skills, communicating clearly in meetings or presentations
  • Excellent written communication skills, writing clear reports, emails, or policies
  • Proficient in the use of MS Excel and Word
  • Demonstrated experience serving in a supervisor role and leading teams
  • Knowledge and application of regulatory guidance to experimental planning and design
  • Experience working in GxP environments and demonstrated knowledge of GxP regulations
Responsibilities
  • Lead team(s) developing and validating bioanalytical assays for support of preclinical, clinical and product release studies
  • Motivating team by inspiring employees to achieve goals and aligning employee goals with company strategy by understanding trends and operations, managing departmental budgets and resources, and being the expert in using tools/software relevant to the team
  • Work closely with clients to assure successful on time execution of assays, validation, and sample analysis under GxPs
  • Prioritizing tasks and managing schedules efficiently
  • Meet regularly with lab management to ensure instrument resources and employees are utilized effectively across all teams
  • Responsible for team performance and outcomes
  • Leading teams through transitions and new initiatives
  • Design and execute experiments efficiently and assign tasks appropriately to employees based on skills
  • Anticipating and mitigating potential problems and handling disputes calmly and fairly
  • Present data and posters
  • Conduct group team meetings to understand employee’s input and concerns, give constructive and timely feedback, and implement 1:1 meetings with employees on a regular basis
  • Hiring and building a team that is knowledgeable and cooperative by investing in the employees’ professional growth, setting goals and evaluating results
  • Identify new analytical techniques and technologies and lead their implementation
  • Review analytical instrument and equipment calibration, qualification and maintenance records
  • Perform statistical analysis
  • Write and review reports and prepare SOPs
  • Fulfill the role of Bioanalytical Project Manager (BPM)/Principal Investigator (PI) for all assigned clients and studies
  • Lead regularly scheduled client meetings to ensure effective communication and manage client expectations
  • Provide client satisfaction and great science
  • Achieve corporate revenue targets
  • Other duties as needed

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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