Biosample Operations Manager

Vor 3 Tagen


Basel, Schweiz Monte Rosa Therapeutics Vollzeit

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.

**Requirements**:

- BS/MS in Biological/Life/Health sciences, 5+ years of relevant industrial experience supporting Pre Clinical and Clinical Samples
- 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
- Excellent computer skills for compiling sample/data reports/presentations

Qualifications


  • Operations Manager

    vor 7 Monaten


    Basel, Schweiz Smood Vollzeit

    Smood ist einer der führenden Lieferdienste in der Schweiz. Unser Ziel ist es, das Leben der Menschen in allem, was wir tun, zu verbessern. Als Unternehmen im Bereich des Food-Tech verbindet Smood Schweizer Konsumenten mit über 2000 Restaurants und 80 Migros-Filialen. Wir erforschen ständig neue Dienstleistungen, um unser Kernangebot zu erweitern. Alle...


  • Basel, Schweiz CORNFELD Executive Search, Zurich Vollzeit

    CORNFELD unterstützt führende Industrie - und Technologiekonzerne mit Hauptsitz in der Schweiz in der Suche und Auswahl des Managements und sucht in diesem Zusammenhang den Kontakt zu einem erfahrenen Operations Manager mit breiter Führungserfahrung auf strategischer Managementebene. Aufgaben Sie haben breite Management-Erfahrung in der Führung...


  • Basel, Schweiz Brenntag Vollzeit

    **Manager Site Operations**: Our team in **Basel** currently has an opening for a **Manager Site Operations** **YOUR ROLE & RESPONSIBILITIES**: - Leitung des Tagesgeschäftes am Standort Basel und Muttenz für folgende Fachbereiche a) Feststofflagerung b) Lagerung und Produktion im Bereich Säuren/Laugen sowie Lösungsmittel c) Arbeitsvorbereitung (AVOR) -...


  • Basel, Schweiz Viking Cruises Vollzeit

    Viking is a strong and dynamic company - with a growing fleet of more than 80 river ships, seven ocean vessels, two explorer ships and a Mississippi River ship. Our guests experience all the comfort and elegance of our award-winning fleet cruising over 100 itineraries around the world. The Junior Purchasing Manager Operations is accountable for placing...


  • Basel, Schweiz NYM Vollzeit

    We are a Privacy Tech based in Neuchâtel and London, building the next generation of privacy infrastructure for the Internet. The Nym team is a world class mix of privacy experts, coders, and thinkers spread all over Europe. We believe that user privacy underpins democratic freedoms in a networked world, and we’re proud to help roll back the surveillance...


  • Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    Job SummaryWe are seeking a highly skilled Global Payroll Operations Manager to join our team in Basel, Switzerland and Manchester, UK. As a key member of our global payroll operations team, you will be responsible for the end-to-end processes related to payroll and time management.


  • Basel, Schweiz questW GmbH Vollzeit

    On behalf of one of the fastest growing Fintech companies in the intersection of Finance and Blockchain, we’re seeking a People Operations Manager who is ready to work in an agile and forward-thinking organization. Reporting directly to the Head of People & Talent, you’ll be joining an amazing team working at the forefront of new ideas that are built...


  • Basel, Schweiz Experis Switzerland Vollzeit

    Business Operations Coordinator A very well-known IT company is looking for a Business Operations Manager. Location: Zurich Duration: 18 months As an Operations Manager / Coordinator, you will play a pivotal role in ensuring the seamless functioning of the marketing department. Your responsibilities will encompass a wide range of operational tasks aimed...


  • Basel, Schweiz BeiGene Vollzeit

    General Description: - May be assigned line management responsibilities of managers, associate managers, senior associates, associates, junior associates, GCP compliance managers and/or - global clinical study leadership of large, global, complex or multiple smaller studies in phase I-IV - Demonstrates a high level of clinical operations knowledge,...

  • Cloud Operations Manager

    vor 7 Monaten


    Basel, Schweiz ABB Vollzeit

    **Cloud Operations Manager**: **Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender, LGBTQ+, abilities, ethnicity and generations. Together, we are...


  • Basel, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a** **Pharmacovigilance (PV) Operations Manager** in our Zurich office. **Here, you will be a vital contributor to our inspiring, bold mission.** The Vaccine Pharmacovigilance Operations Manager provides support to Takeda’s Vaccine...

  • R&d Operations Manager

    vor 6 Monaten


    Basel, Schweiz ABB Vollzeit

    **R&D Operations Manager**: **Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender, LGBTQ+, abilities, ethnicity and generations. Together, we are...


  • Basel, Schweiz Google Vollzeit

    Minimum qualifications: - Vendor management experience in an Managed Service Provider (MSP) environment. - Experience with field operations across multiple geographical regions and continents. - Experience managing projects across multiple verticals, industries, and/or geographical areas. - Experience in people management, leading projects and managing a...

  • Operations Manager

    Vor 6 Tagen


    Basel, Basel-Stadt, Schweiz Project Delivery Partners Vollzeit

    Job Overview:We are seeking an experienced Operations Manager to join our team at Project Delivery Partners. The ideal candidate will have a strong background in Process Commissioning and Qualification, with a focus on Fill Finish and Process Support Equipment.


  • Basel, Schweiz Ultragenyx Pharmaceutical Vollzeit

    **Why Join Us?** - Be a hero for our rare disease patients_ Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside...


  • Basel, Schweiz Herzog & de Meuron Vollzeit

    Herzog & de Meuron ist ein international tätiges Architekturbüro mit Sitz in Basel und weiteren Büros in Dänemark, Deutschland, Hong Kong, UK und USA. Für unser Büro in Basel suchen wir per sofort oder nach Vereinbarung eine.n erfahrene.n Junior Resource Manager Operations Ihr Profil: - Hochschulabschluss (Uni/FH) oder entsprechende Qualifikation...


  • Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: This role is an exciting opportunity to be part of a growing CMC international organization, responsible for the manufacturing and supply of Moderna’s COVID mRNA vaccine internationally, as well as preparation for commercial manufacturing for further projects coming via our pipeline. Reporting to the Director, International Operations, the...


  • Basel, Schweiz AL Solutions Vollzeit

    Liam Newton has partnered with a mid-large size Pharma who specialise within rare diseases. They are searching for an experienced Clinical Operations Manager, based in Basel. It is a 12 months contract with possibility of extension. It is mainly on site, based in Basel where you would be a part of a fantastic team where you would closely collaborate with...


  • Basel, Schweiz Indivi Vollzeit

    **Your mission**: Indivi is a medical technology company enabling precision medicine to become a reality in neuroscience research and development. The company is going through significant growth and looking for new team members to join and contribute to making the company vision a reality. **Your profile**: **Responsibilities and Requirements**: **Study...


  • Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: The Regulatory Operations Submission Manager is responsible for the planning, managing and tracking of regulatory submissions. In collaboration with the Regulatory Lead, he/she plans and prepares high quality global submissions, in-house or via CRO, ensuring delivery of compliant submissions to global health authorities in a timely manner. The...