Join to apply for the Biosample Operations Manager role at Monte Rosa Therapeutics. The Biosample Operations Manager will be accountable for the clinical and non‑clinical sample planning, processing, tracking, reconciliation, and life‑cycle management to maintain chain‑of‑custody in a GxP‑compliant setting.
Responsibilities
* Manage clinical and non‑clinical samples, maintain sample chain‑of‑custody in a GxP‑compliant setting
* Plan and coordinate clinical sample logistics with Clinical Operations, Biomarker sub‑teams, clinical sites, external labs, vendors and couriers to define sample processing and movement timelines needed for testing and transfer
* Oversee all operational activities to ensure high‑quality sample processing, shipping, receiving, and storage
* Manage external sample processing laboratories and vendors, including contract development, sample preparation training, file transfer, document review, compliance monitoring and problem solving
* Develop and review specialty lab manuals, SOPs, equipment methods, sample labels and other controlled documents related to sample management
* Oversee clinical sample life‑cycle management and drive innovative sample‑management process improvement
* Support Translational Medicine and assay teams with sample timelines and technical/operational matters
* Partner with the Biomarker Lead to establish a biomarker plan
* Coordinate with cross‑functional teams to support research sample generation and allocation
* Resolve sample‑related issues in a timely manner in collaboration with clinical operations, CROs and clinical sites
* Receive and register samples into the biomarker LIMS system and process them in-house
* Coordinate shipments of clinical samples to the off‑site biobank for long‑term storage after internal testing
Qualifications
* BS/MS in Biological/Life/Health sciences
* 5+ years of relevant industrial experience in clinical sample collection, processing, tracking, reconciliation and storage
* Extensive experience with clinical sample chain‑of‑custody management in a GxP, ICH/GCP, CAP/CLIA regulated environment
* Proficiency with Laboratory Information Management System (LIMS) and controlled document writing/review
* Familiarity with clinical biomarker sample preparations and pharmacokinetics
* Strong organizational, planning and time‑management skills with attention to detail
* Excellent analytical, problem‑solving, oral and written communication skills
* Strong interpersonal and collaboration skills
* Proficiency in computer skills for compiling sample/data reports and presentations
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