Job Details Senior Manager , Biospecimen & Biomarker Operations Job Code #: 26BMOPS-1 Status: Exempt, Full Time Reports to: SVP Translational Sciences, Genetics, and Bioinformatics Department: Bioinformatics and Genetics Location: San Diego , CA (on-site, 5 days/week) Contact: careers@actiobio.com About Us! Actio Biosciences, Inc., is a drug discovery and development company grounded in the science of precision medicine. Actio is developing a portfolio of drugs to modulate the activity of proteins responsible for rare diseases with the goal to also translate these findings into treatments for common diseases with shared underlying disorders. Actio has built an integrated discovery engine with deep human genetics, bioinformatics, and drug discovery expertise. Actio was founded in October 2021, and is funded by Canaan, Deerfield Management, Droia, EcoR1 and Euclidian Capital. Come join an exciting and rapidly growing team dedicated to discovering transformational therapies for patients with severe unmet medical needs. At Actio, our employees are passionate about their work and believe in the power of teamwork, collaboration, an d mutual respect. Visit: www.actiobiobiosciences.com About You! Reporting directly to the SVP Translational Sciences, Genetics, and Bioinformatics , the Senior Manager of Biospecimen & Biomarker Operations will own end-to-end biospecimen operations across Actio's preclinical and clinical pipelines. This is a pivotal role that enables the company's biomarker programs and supports both early - and later -stage clinical trials - including studies with ex -US components. This role combines direct, hands-on biospecimen operations with management of external vendors, CROs, and central laboratories. You will partner closely with Translational Sciences, Bioinformatics, Clinical Operations, and Biology to mature and scale the biospecimen function on top of established CRO relationships and SOPs . If you thrive in a dynamic, science -rich environment and have a strong service orientation toward the multidisciplinary teams that depend on biospecimen quality and integrity, we want to hear from you. You will be responsible for: Vendor Qualification & Analytical Validation • Lead selection, qualification, and ongoing performance management of central laboratories, biorepository CROs, and bioanalytical vendors. • Drive fit-for-purpose analytical validation studies for biomarker assays, including validation and qualification work to support biomarkers used as efficacy outcomes in clinical trials. • Review and approve vendor validation reports, sample acceptance criteria, calibration records, and analytical run release criteria. • Author and manage Statements of Work and Quality Agreements with vendors. Chain of Custody & Logistics • Own end -to-end chain of custody from collection site to analytical laboratory and into the LIMS for every preclinical and clinical biospecimen. • Author and maintain trial -specific Laboratory Manuals; train clinical sites on biospecimen collection, pre -analytical handling, cold -chain shipping, and prioritization rules for pediatric and low -volume draws. • Oversee inbound shipments, accessioning, and reconciliation; manage banked aliquots and re -analysis workflows prior to database lock. Ex-US & Multi -Region Operations • Navigate the operational and regulatory complexity of international biospecimen programs: import/export permits, customs documentation, country -specific regulations, GDPR and cross -border data privacy, local ethics requirements, and IATA-compliant cold -chain shipping. • Coordinate with ex -US central laboratories, regional CROs, and site collection teams across time zones. Quality Assurance & Regulatory Compliance • Own the GCP (ICH E6), HIPAA, IACUC, and 21 CFR Part 11 compliance posture for biospecimens and associated metadata. • Author and maintain SOPs covering sample collection, processing, storage, shipping, retention, destruction, and chain of custody. • Lead deviation investigations, CAPAs, and inspection readiness; partner with Quality Assurance on internal and vendor audits. LIMS Infrastructure & Sample Data Architecture • Partner with Bioinformatics to specify, configure, and steward the LIMS supporting biospecimen and biomarker data. • Define sample data models linking pre -analytical metadata, assay results, and clinical data, ensuring Part 11 audit trails and downstream traceability. • Drive continuous improvement of integrations between the LIMS, clinical data management systems, and analytical data feeds from central laboratories. Preclinical Biorepository Operations • Manage receipt, accessioning, banking, and tracking of preclinical samples from external CRO and academic partners (e.g., Jackson Laboratories, university collaborators). • Coordinate Material Transfer Agreements, IACUC -aligned documentation, and chain of custody from external vivaria into Actio's biorepository. Cross-Functional Collaboration • Provide biospecimen and biomarker operations input into protocol development, Biomarker Analysis Plans, Laboratory Manuals, and regulatory submissions. • Represent biospecimen operations to internal Data Review Committees, Data Safety Monitoring Boards, and external regulatory reviewers as needed. • Communicate operational status and data findings to multidisciplinary teams through oral presentations and written technical reports. Other duties as assigned . You have the following skills and qualifications: • BS with 10+ years, MS with 8+ years, or PhD with 5+ years of relevant experience in biological sciences, biochemistry, clinical laboratory science, or a related field. • Demonstrated experience leading biospecimen operations in a pharma, biotech, or CRO setting, including direct ownership of vendor qualification and oversight for biomarker or clinical laboratory assays. • Hands-on experience designing and executing analytical validation studies for biomarker assays, including those used as efficacy outcomes in interventional clinical trials (CLIA, GLP, or GCLP contexts). • Working knowledge of GCP, HIPAA, IACUC, and 21 CFR Part 11 as applied to biospecimen and biomarker data. • Experience managing biospecimen logistics for multi -region or international clinical trials, including import/export documentation, customs, and country -specific regulatory requirements. • Experience implementing or stewarding a LIMS and defining sample data models in collaboration with informatics or IT teams. • Track record managing chain of custody and pre -analytical quality for both clinical trial and preclinical samples. • Excellent project management, organizational, and written and verbal communication skills. • Detail-oriented, self -motivated, and comfortable moving between hands -on bench operations and vendor management. Preferred qualifications : • Experience supporting neurology or neuromuscular biomarker programs. • Familiarity with central -lab immunoassay and emerging proteomics platforms used in clinical biomarker testing. • Prior experience supporting validation and qualification of biomarkers used as efficacy outcomes in clinical trials. • Experience with European, Asian, or other ex -US regulatory environments for biospecimen handling and human -genetic-material movement. • Experience with pediatric trials, including low -volume sample handling and analyte prioritization rules. • IATA Dangerous Goods certification, or willingness to obtain. • Working familiarity with longitudinal biomarker analytical frameworks sufficient to communicate effectively with biostatistics and translational sciences partners. Why Actio? The work culture at Actio fully embraces teamwork, collaboration and mutual respect. We believe that our employees are our greatest asset, and we strive to create an inclusive and empowering environment where everyone feels valued and respected for who the y are. We encourage our employees to bring their unique perspectives and experiences to the table and we believe that this diversity is what makes us stronger as a team. We invest in supporting our employees to succeed both at work and at home, and we bel ieve that a good work -life balance is essential for everyone's well -being. If you thrive in an environment where you are inspired by others and empowered to participate to your fullest potential alongside exceptionally talented and kind human beings - Actio is the place for you! Compensation & Benefits We are committed to ensuring all employees, both current and future, receive fair and equitable pay. Base pay is one component of the total compensation package, and is determined within a range according to role, level, and location. This provides the opportunity for growth as you gain experience and develop within a role, while also allowing for differentiation based on performance. The base pay range for this role is $170,000 to $190,000 and reflects our good -faith estimate of the minimum and maximum tar get for the position as of the date of posting and may be modified in the future. The final base pay within the range will be determined by work location and additional factors, including job -related skills, experience, relevant education or training, and market demand for your expertise. Benefits programs offered include: • Medical, dental and vision insurance (employee premiums covered by Actio at 90%) • Health Savings Account with a rich employer contribution • Flexible Savings Account for healthcare and dependent care • Mental health and wellness benefits • 401k plan participation • Equity Incentive Plan participation (stock options) • Life/AD&D/ST and LT Disability Insurance (premiums covered by Actio at 100%) • Supplemental benefits including legal service s, pet insurance , and other optional coverage • Weeklong winter holiday shutdown , generous paid time off , and holiday policies • And more! Details of participation in these benefit plans will be provided with an employment offer. Actio benefits and compensation programs are subject to eligibility requirements and other terms of the applicable plan or program. Equal Opportunity Employer Actio is committed to building a diverse workforce and providing equal employment opportunities to all employees and applicants for employment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, n ational origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. The above is intended to describe the general content of, and requirements to perform this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. How to Apply To apply, please send your CV/resume and cover letter by email to: careers@actiobio.com , and reference Job Code #: 26BMOPS -1 in the subject field.