At Altum Sequencing, we are dedicated to transforming cancer diagnostics and monitoring through cutting-edge genomic technologies. As Laboratory Manager, your mission is to lead the daily operations and continuous improvement of our molecular biology and sequencing laboratory, ensuring scientific excellence, operational efficiency, and full compliance with ISO 1518 / 13485, FDA and IVDR standards.
You will be responsible for building and mentoring a high-performing lab team, optimizing workflows for clinical and research-grade assays (including NGS and ctDNA analyses), and fostering a quality-driven culture. Your role is critical in bridging the gap between the scientific team, quality management, and clinical partners, ensuring that every sample processed brings us closer to improving outcomes for patients with cancer.
Tasks
* Oversee daily laboratory operations, ensuring timely, accurate, and high-quality execution of molecular and sequencing-based assays (including NGS, PCR, and ctDNA workflows).
* Ensure full compliance with ISO 15189, ISO 13485, FDA and IVDR requirements in all laboratory processes, documentation, and reporting.
* Lead, train, and mentor the laboratory team, fostering a culture of accountability, continuous improvement, and scientific excellence.
* Develop, implement, and maintain SOPs, quality control protocols, and validation plans for new and existing assays in alignment with regulatory and accreditation standards.
* Collaborate with Quality Assurance and Regulatory Affairs to support audits, inspections, non-conformity investigations, and CAPA implementation.
* Manage laboratory resources, including budgeting, purchasing, inventory control, equipment maintenance, and vendor relationships.
* Act as liaison with cross-functional teams (R&D, Bioinformatics, Clinical Affairs, and Management) to align lab activities with project timelines and strategic goals.
* Drive process optimization and automation initiatives to increase efficiency, scalability, and reproducibility of laboratory workflows.
* Ensure a safe working environment by enforcing laboratory safety protocols and compliance with health and safety regulations.
* Monitor and report laboratory KPIs, and actively contribute to monthly management reviews and strategic planning sessions.
Requirements
1. Educational Background
* A Bachelor’s degree in Molecular Biology, Biochemistry, Biotechnology, Biomedical Sciences, or a related field (required).
* A Master’s degree or PhD in a relevant discipline (preferred), especially with a focus on molecular diagnostics or oncology.
* Additional certifications in Quality Management, Clinical Laboratory Science, or Regulatory Affairs are considered an asset.
2. Professional Experience
* At least 5 years of experience in a molecular biology or clinical diagnostics laboratory, with strong hands-on involvement in NGS workflows, PCR, and/or ctDNA analysis.
* A minimum of 2 years in a supervisory or managerial position, ideally within an ISO-accredited and/or IVD-regulated environment.
* Demonstrated experience with assay validation, documentation practices, and quality control in a clinical or translational setting.
3. Regulatory & Quality Knowledge
* Solid understanding of international standards and regulations, including:
* ISO 15189 (medical laboratories)
* ISO 13485 (medical devices and IVDs)
* FDA 21 CFR Part 820 (Quality System Regulation)
* EU IVDR 2017/746
* Experience with internal audits, non-conformance investigations, and CAPA implementation.
4. Technical Proficiency
* Proven ability to manage and troubleshoot high-throughput workflows involving NGS library preparation, sequencing, and data quality review.
* Familiarity with LIMS, laboratory automation systems, and QC monitoring tools.
* Experience working with clinical samples, UMIs, and low-input or high-sensitivity molecular assays (e.g., MRD panels).
5. Leadership & Communication
* Strong leadership skills with a track record of successfully managing technical teams and driving performance in a regulated lab environment.
* Excellent organizational, time management, and problem-solving abilities.
* Ability to communicate effectively with multidisciplinary teams, including QA/RA, clinicians, researchers, and senior management.
* Fluent in English (written and spoken); proficiency in Spanish is a plus.
Benefits
* Mission-Driven Impact – Be part of a team fighting cancer through cutting-edge liquid biopsy and MRD technologies.
* Deep Tech Environment – Collaborate with top scientists and engineers at the forefront of bioinformatics and NGS innovation.
* Flexible Work Setup – Hybrid and remote options available, with core hours adapted to scientific workflows.
* Continuous Learning – Access to conferences, courses, and internal knowledge-sharing sessions.
* Collaborative Culture – Work cross-functionally with clinical, R&D, and product teams in a fast-growing startup.
At Altum Sequencing, we believe that our people are our most valuable asset. We are committed to creating a purpose-driven, inclusive, and rewarding environment where scientific talent can thrive and contribute to real impact in patients’ lives. As a member of our team, you will benefit from:
Mission-Driven Work
* Be part of a cutting-edge company focused on transforming cancer care through precision diagnostics and real-time MRD monitoring.
* Contribute to meaningful projects that directly impact clinical decisions and patient outcomes.
Professional Growth & Development
* Work in a multidisciplinary, innovation-driven environment where learning and collaboration are at the core.
* Access to internal and external training opportunities, including certifications, conferences, and scientific development.
* Defined career progression pathways, with the opportunity to take on increasing responsibility and leadership.
Modern, Dynamic Workplace
* A fast-paced biotech start-up culture with a strong focus on agility, creativity, and teamwork.
* Access to state-of-the-art laboratory infrastructure and technologies, including advanced NGS platforms and automation systems.
Inclusive & Collaborative Culture
* Flat organizational structure that encourages ownership, open communication, and idea-sharing.
* A supportive team where your voice is heard and your contributions are recognized.
Stability with Flexibility
* Competitive salary package, aligned with your experience and the impact of your role.
* Flexible working hours.
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