--- title: 'Data Management Specialist at BioAgilytix' canonical: 'https://feeny.ai/job/data-management-specialist-bioagilytix-durham-rhpbfq2gbpsr' type: 'job' last_seen: '2026-09-25' --- # Data Management Specialist at BioAgilytix - **Company:** BioAgilytix - **Location:** Durham, NC - **Work type:** onsite - **Posted:** 2026-09-23 - **Last confirmed live:** 2026-09-25 - **Apply:** https://jobs.lever.co/bioagilytix/5e7fd264-8ade-4930-970a-eb79b873aa0a ## Job description 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. The Sample Management Specialist is responsible forGxP-compliant processing of incoming and outgoing samples and reference materials. Essential Responsibilities - Generates and maintains records in a GxP-compliant manner - Builds study sample metadata in LIMS - Prepares sample manifest files for import into electronic sample management systems (eSMS) - Resolves discrepancies and updates electronic information - Ensures data integrity and traceability - Develops/validates SM software solutions - Collects and presents metrics data - Participates in audits/inspections as appropriate - Provides information for QAU, client, or regulatory agency audit reports as needed - Trains new Sample Management Specialists - Assists with drafting Sample Management SOPs - Recommends/enacts process improvements - May train new Data Management Specialists as needed - May receive samples as needed: - Receives shipments into Sample Management - Initiates sample chain-of-custody - Provides timely notification of sample receipt to client/BPM - May ship samples to domestic or international destinations as needed - May accession samples as needed: - Accessions samples into LIMS - Imports electronic sample metadata into eSMS - Resolves discrepancies, with responsibility for investigating and correcting sample anomalies - Manages pre- and post-test sample storage - Pulls samples for testing per schedule/request - Checks out pre-test samples and checks in post-test samples - Follows BAL SOPs Minimum Preferred Qualifications: Education/Experience - High School diploma and not less than eight (8) years’ experience in sample management in a biotech or pharmaceutical GxP-regulated environment Minimum Preferred Qualifications: Skills - Working knowledge of GxP regulations - Ability to work in a fast-paced team environment where multiple concurrent projects must be completed in a timely manner - Ability to take direction well and multi-task - Acute attention to detail and excellent organizational skills - Excellent oral and written communication skills - Proficiency in MS Excel and Word - Proficiency in LIMS and Quality Management software packages ## Preferred Credentials - Associate degree in biological science or related field and not less than six (6) years’ experience in sample management in a biotech or pharmaceutical GxP-regulated environment - Bachelor’s degree in biological science or related field and not less than four (4) years’ experience in sample management in a biotech or pharmaceutical GxP-regulated environment Supervision Received - Infrequent supervision and instructions - Frequently exercises discretionary authority 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 ## 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 BioAgilytix ## Company Overview - **One-liner**: BioAgilytix is a global contract research organization providing GxP-compliant bioanalytical testing services to support pharmaceutical and biotech partners in all phases of drug development. - **Entity Type**: Private (funded) - **Headquarters**: Durham, North Carolina, United States - **Founded**: 2008 - **Founders**: Not publicly available ## Core Business - **Primary Industry**: Biotechnology Research / Bioanalytical Contract Research Organization (CRO) - **Target Customers**: B2B; specifically top pharmaceutical and biotechnology companies developing cutting-edge therapies. - **Mission or Purpose Statement**: To deliver innovative and reliable bioanalytical testing solutions, providing data and insight which lead to better, faster decisions on drug candidates in development. ## Products & Services BioAgilytix offers a comprehensive suite of laboratory services, primarily conducted under non-GLP, GLP, GCP, and GMP quality control testing: - **Pharmacokinetics (PK) Services**: Assay development, validation, and sample testing for small molecules, large molecules, and advanced drug modalities. - **Immunogenicity Services**: Screening, characterization, and neutralizing antibody assays to optimize drug safety, leveraging deep expertise in unwanted biotherapeutic-induced immunogenicity. - **Biomarker Analysis**: Fit-for-purpose biomarker assay development and testing from a menu of over 120 off-the-shelf assays, supporting clinical trial efficacy and safety. - **CMC Analytical Services**: Cell-based potency assays, molecular assays, mass spectrometry characterization, and other analytical methods supporting therapeutics from pre-IND to commercial release testing. - **Diagnostic Testing Services**: Offered at its CLIA-certified, CAP-accredited Boston laboratory. ## Market Standing - **Valuation/Market Cap**: Not disclosed (private company) - **Key Metric**: Annual Revenue of **$130M**; **$30.1M** in total funding from one prior round. - **Notable Investors/Partners**: Not specifically named in available sources. They support 21 of the world’s top 25 biopharma companies and supported ~30% of FDA-approved biologics from 2020 to 2024. - **Growth Signals**: - **1,100+ employees**, with a headcount growth of 2.1% YoY (+19 people) to 698 (according to LinkedIn, which may be lower than the company's self-reported total). - **Industry-leading employee retention rate of 90%**. - Global presence with labs in Durham, NC; Boston, MA; San Diego, CA; Hamburg, Germany; Melbourne and Brisbane, Australia; and partner labs in Beijing, China. ## Competitive Advantages - **World-Class Expertise**: Over 50% of scientists hold PhD and/or master’s degrees; the science team averages over 10 years of bench experience. - **Proven Track Record**: Supported ~30% of FDA-approved biologics between 2020 and 2024 and works with 21 of the top 25 global biopharma companies. - **Global Scale & Local Reach**: Operates in key biopharma hubs across the US, Europe, and Australia, with partner labs in China, enabling seamless global study transitions. - **High Retention**: A 90% employee retention rate indicates strong workplace satisfaction and internal stability. - **Comprehensive Capabilities**: Offers an "industry’s most complete set of capabilities," from assay development to commercial batch release, providing a consultative, scientist-to-scientist partnership model. ## Strategic Focus Based on available materials, BioAgilytix is focused on continued expansion of its global footprint (notably in Australia and Europe), deepening its expertise in advanced drug modalities (cell and gene therapies, oligonucleotides), and maintaining its leadership in bioanalysis for biologics. Its strategic focus is to proactively anticipate assay challenges to keep partner drug development timelines on track. ## Why Work Here - **Culture & Mission**: BioAgilytix fosters a culture of diversity, equity, and inclusion, supported by employee resource groups (ERGs). Employees solve "mission-critical bioanalytical solutions" that help bring therapies to patients faster. - **Work Policy**: Roles are **on-site** at specific lab locations (e.g., San Diego, CA; Melbourne, Australia; Durham, NC). This is a lab-based scientific organization. - **Benefits (US)**: Competitive compensation, health/dental/vision insurance, 401(k) savings plan, paid time off, paid parental leave, short- and long-term disability, group life insurance, employee assistance programs, adoption and fertility support, pet insurance, and legal assistance. - **Professional Development**: Access to high-visibility industry forums, continuous learning platforms, and opportunities to work on cutting-edge therapies for the world’s top pharma companies. ## Sources 1. [bioagilytix.com](https://www.bioagilytix.com/) 2. [bioagilytix.com - Careers](https://www.bioagilytix.com/about/careers/) 3. [bioagilytix.com - Corporate Brochure](https://www.bioagilytix.com/wp-content/uploads/2026/03/BioAgilytix-Corporate-Brochure-March-2026.pdf) 4. [linkedin.com](https://linkedin.com/company/bioagilytix) 5. 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