Job Description

BioSample Operations Manager



Location: Basel, Switzerland



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.



Primary Responsibilities


Manage clinical and non-clinical samples, maintain sample chain-of-custody in a GxP-compliant setting

Accountable for clinical sample logistic planning and coordination with Clinical Operations/Biomarker sub-teams, clinical sites, external labs, vendors, and couriers to define sample processing and movement timelines needed for sample testing and transfer. Oversee all operational activities required to ensure high quality sample processing, shipping, receiving, and storage

Manage external sample processing laboratories and vendors, responsible for contract development, sample preparation training, file transfer, document review, compliance monitoring and problem solving

Responsible for development and review of specialty lab manuals, SOPs, equipment methods, sample labels and other controlled documents related to sample management

Oversee clinical sample life-cycle management, responsible for innovative sample management process improvement.

Support Translational Medicine and other assay teams as needed to provide information on sample timelines and other sample related technical and operational matters.

Partner with Biomarker Lead to establish biomarker plan

Coordinate with cross-functional teams to support research sample generation and allocation

Work closely with clinical operations/CROs and/or clinical sites to resolve sample related issues in a timely manner

Responsible for receiving and registering into the biomarker LIMS system, clinical samples which will be processed in-house.

Coordinating shipments of clinical samples to off-site biobank for long term storage upon completion of internal testing.


Competencies


Clinical sample chain-of-custody management, extensive experience with clinical sample collection, processing, tracking, reconciliation, and storage

Familiarity with GxP, ICH/GCP, CAP/CLIA regulations

Experienced with sample management Laboratory Information Management System (LIMS)

Experienced with controlled document writing and review

Working knowledge with clinical biomarker sample preparations and clinical pharmacokinetics


Required Skills


Strong organization, planning, and time management skills.

Attention to details, strong analytical and problem-solving skills

Excellent oral and written communication skills

Strong inter-person and collaboration skills

5+ years of relevant industrial experience

Excellent computer skills for compiling sample/data reports/presentations


Qualifications



BS/MS in Biological/Life/Health sciences





Interested Candidates may forward a CV and Cover Letter in a single PDF via our on-line portal https://www.monterosatx.com/careers/





Monte Rosa Therapeutics is a clinical-stage biotechnology company developing highly selective molecular glue degrader (MGD) medicines for patients living with serious diseases in the areas of oncology, autoimmune and inflammatory diseases, and more. MGDs are small molecule protein degraders that have the potential to treat many diseases that other modalities, including other degraders, cannot. Monte Rosa's QuEEN(TM) (Quantitative and Engineered Elimination of Neosubstrates) discovery engine combines AI-guided chemistry, diverse chemical libraries, structural biology, and proteomics to rationally design MGDs with unprecedented selectivity. Monte Rosa has developed the industry's leading pipeline of MGDs, which spans autoimmune and inflammatory diseases, oncology, and beyond. Monte Rosa has a global license agreement with Novartis to advance VAV1-directed molecular glue degraders and a strategic collaboration with Roche to discover and develop MGDs against targets in cancer and neurological diseases previously

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Company

Monte Rosa Therapeutics AG
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Location

Basel, Switzerland




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Categories

Therapeutics/vaccines (human)


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Type of job

Research


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Contact information

HR


careers-basel@monterosatx.com