External Manufacturing Operations Lead

vor 2 Wochen

Freiburg, Freiburg, Schweiz Talentor Sweden AB Vollzeit

Responsibilites

  • Interacts with biological Contract Manufacturers (CMOs, internal/external) in order to supply biological Drug Substances in the required quality, quantity, timing and cost; following defined production schedules, quality agreement and established manufacturing contracts.
  • Support and Manage technical projects (process and analytical transfers, validations and optimization projects) at CMOs and coordinate any associated required regulatory documentation
  • Ensures efficient Operational interaction with CMOs producing biological Drug Substances:
  • Ensure availability of up-to-date GMP documentation at CMOs to ensure compliance of production (e.g. process descriptions, raw material reports, product specifications ).
  • Ensure efficient communication with CMOs by organizing regular meeting (call or F2F) as appropriate and ensure that minutes of those meeting with action list (if required) are prepared.
  • Track production and technical transfer activities at CMOs in line with procedures
  • Manage deviation and change control in system and provide timely response to CMOs.
  • Monitor process performance at CMOs by reviewing the production data trending and annual product review.
  • Ensures long term management of CMOs for commercial production.
  • Define process improvement implementation roadmap in collaboration with internal functions and CMOs.
  • Lead project for implementation (tech transfer) / modification of manufacturing processes and analytical methods at CMOs.
  • Write/review of the CMC sections to ensure coherence with effective manufacturing process.

Requirements:

  • Min. 5 years of experience in pharmaceutical industry
  • Min 5 years of experience in Quality Assurance and CMO management
-
Fluent French
Mandatory:Skilled in cGMP quality and regulatory requirements in the manufacture of NBEs Understanding of analytical development for recombinant protein products, including analytical characterisation and routine release testing Skilled at writing and reviewing technical documentation, including cGMP documents and regulatory submissions relating to biological products

  • Director Manufacturing

    vor 2 Wochen

    Freiburg, Freiburg, Schweiz Bio-Rad Laboratories Vollzeit

    Présentation:For our site in Cressier (FR), we are looking for a Director Manufacturing - Immunohematology (M/F/d) - 100%.How You'll Make an Impact: Manage manufacturing operations on one or several plants, including Switzerland:Ensure yearly production plan on the different plants and avoid product shortage Ensure quality of products, customer satisfaction...

  • Lead Operation

    vor 2 Wochen

    Freiburg, Freiburg, Schweiz swisspro Vollzeit

    **Du suchst eine abwechslungsreiche Herausforderung, bei der du die Zukunft der Technologie mitgestalten kannst?****Werde Teil unseres innovativen Teams und gestalte mit uns die Zukunft****Dein Gestaltungsraum**- Als Lead Operation & Technology Grid (alle) trägst du die Verantwortung für das Ressort Grid Communications. Du bist nicht nur für die...

  • Global Manufacturing Process Manager, Center of

    vor 2 Wochen

    Freiburg, Freiburg, Schweiz FMC Corporation Vollzeit

    _This role can be based either in Hørsholm, Denmark or in Geneva, Switzerland._About FMCFMC is an agricultural sciences company that advances farming through innovative and sustainable crop protection technologies. FMC invests significant resources in discovering new active ingredients, developing innovative formulations and biologicals in addition to...

  • Global Environmental Operations Lead

    vor 2 Wochen

    Freiburg, Freiburg, Schweiz Hitachi Energy Ltd Vollzeit

    Location:Zurich, Zurich, SwitzerlandJob ID:HQDate Posted:Company Name:Hitachi Energy LtdProfession (Job Category):Legal, Compliance & AuditJob Schedule:Full timeRemote:YesJob Description:General information: As Global Environmental Operations Lead you will provide operational direction and support to contribute to environmental performance, including energy...

  • Lead, Global Distribution Network Performance

    vor 2 Wochen

    Freiburg, Freiburg, Schweiz Takeda Pharmaceutical Vollzeit

    About the role**: Deliver a Unique Customer Experience through a Selfdriving, Agile, Compliant and Regional differentiated distribution network guided by our commitment to the Patients, People and Planet Provide to Global Distribution & Logistics (GD&L) members, OpUs and BUs innovative best practices on performance management and global reporting, acting as...

  • Head of Operations

    vor 2 Wochen

    Freiburg, Freiburg, Schweiz Electra Vollzeit

    What do we do ?:Born in 2021 from the desire to make cities less polluted and less noisy, Electra is helping to shift usage towards electric mobility by tackling the main obstacle of recharging.Electra is constantly innovating to facilitate the recharging of electric vehicles with a network of fast recharging hubs (15 to 30 minutes maximum) and a user...

  • Director of Operations

    vor 2 Wochen

    Freiburg, Freiburg, Schweiz Morgan Philips Executive Search Vollzeit

    We are recruiting on behalf of our client, a top international player in the restaurant industry for a Director of Operations.Accountable for leading and directing restaurant operations leadership of Switzerland. The role can be based either in Geneva or Zurich with 50% of traveling.Responsible for leading, coaching and directing Areas Managers and...

  • Hardware Team Lead

    vor 2 Wochen

    Freiburg, Freiburg, Schweiz Gravis Robotics Vollzeit

    Gravis Robotics is a startup that turns heavy construction machines into intelligent and autonomous robots. Our unique combination of learning-based automation and augmented remote control lets one operator safely conduct a fleet of earthmoving machines in a gamified environment. Our team has over a decade of academic experience honing the cutting edge of...

  • Lead, Product Portfolio and Growth

    vor 2 Wochen

    Freiburg, Freiburg, Schweiz World Economic Forum LLC Vollzeit

    The World Economic Forum, committed to improving the state of the world, is the international organization for public-private cooperation.The Forum engages the foremost political, business, and other leaders of society to shape global, regional and industry agendas.Why we are recruitingWe are seeking a Lead, Product Portfolio and Growth to drive the...

  • Stakeholder Engagement Lead

    vor 2 Wochen

    Freiburg, Freiburg, Schweiz OM Pharma Ltd. Vollzeit

    Location:Meyrin, Geneva, CH- Division:Division: Medical AffairsJob Type: Permanent roleOM Pharma is strengthening its international engagement activities and we are recruiting a Stakeholder Engagement Lead based at our global headquarters in Geneva. Reporting directly to the Head of Medical Affairs, you work in close collaboration with cross-functional...

  • Manager Finance

    vor 2 Wochen

    Freiburg, Freiburg, Schweiz Experis Vollzeit

    Experis is the global leader in professional resourcing and project-based workforce solutions.For our Pharmaceutical client based in Nauchatel, we are looking for a Finance Manager to start on a 6 month contract as soon as possible.General Information:Start Date:ASAPDuration: 6 MonthsLocation: Neuchatel, SwitzerlandJob Type: ContractOVERVIEW:This position's...

  • Finance Business Partner in Operations

    vor 2 Wochen

    Freiburg, Freiburg, Schweiz Migros Industrie AG Vollzeit

    In dieser Funktion unterstützt Du den Finance Business Partner des Bereichs Supply Chain & Operations, sowie die lokalen SCO Controller/Werkscontroller bei der Schaffung von Kostentransparenz, COGS Reviews, Procurement Controlling und Reporting.Interessiert? Dann freuen wir uns auf Deine Bewerbung.**Migros Industrie AG**:- Migros Industrie AG - Zürich-...

  • Quality Leader

    vor 2 Wochen

    Freiburg, Freiburg, Schweiz Thornshaw Scientific Recruitment Vollzeit

    Posted date 16 January 202- LocationZurich Job type Permanent SalaryNegotiable Discipline Life Sciences ReferenceJOQuality Leader - Fachtechnisch verantwortliche Person/FvP - Leading, Global Life Sciences CompanyCPL Life Sciences is recruiting on behalf of a Leading, Global Medical Technology Company, that supports hundreds of thousands of patients on a...

  • Team Leader

    vor 2 Wochen

    Freiburg, Freiburg, Schweiz Swisslinx Vollzeit

    We are looking for a dynamic and visionary leader to join the team of our client in Zurich and help strengthen their cybersecurity efforts. The Cyber Defense team is responsible for detecting potential security threats, implementing preventive measures, managing security incidents, and continuously improving existing processes, tools, and procedures.As the...

  • Head, Centre for Advanced Manufacturing and Supply

    vor 2 Wochen

    Freiburg, Freiburg, Schweiz World Economic Forum LLC Vollzeit

    The World Economic Forum, committed to improving the state of the world, is the International Organization for Public-Private Cooperation.The Forum engages the foremost political, business, and other leaders of society to shape global, regional and industry agendas.The Advanced Manufacturing and Supply Chains (AMSC) Centre provides a unique global platform...

  • Lead Security Operations 80

    vor 2 Wochen

    Freiburg, Freiburg, Schweiz ITpoint Systems AG Vollzeit

    Du bist Teamplayer? Vorwärtsdenker? Mitgestalter?Wir sind Erfolgsverfechter, IT-Liebhaber, NeuerfinderMatch?Dann lass uns mehr erzählenDamit wir unseren Purpose **"Empowering people to do what they love" **leben können, sind unsere Hierarchien flacher als das SeelandWir schätzen Menschen mit Profil, Visionen und der Power zum Anpacken, Umwerfen und...

  • Business Services Lead, Events Strategy and

    vor 2 Wochen

    Freiburg, Freiburg, Schweiz World Economic Forum LLC Vollzeit

    Why we are recruitingThe Forum's 'Business Services' is a central strategy and operations unit that supports the engagement journey of over 850 global and regional organisations across industries.We are currently seeking a Lead who will be responsible for supporting the Business Services team on driving the partner engagement strategy and experience across...

  • Head of Quality Control Operations

    vor 2 Wochen

    Freiburg, Freiburg, Schweiz ARIAD Vollzeit

    At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It's reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you're a part...

  • Lead Investigator

    vor 2 Wochen

    Freiburg, Freiburg, Schweiz Interiman Vollzeit

    INTRODUCTION:For our client, a leading international Pharma company, we are searching for a:Lead Investigator & Quality Control H/F - 100% - 15 months temporary contractThis position is primarily responsible for managing QC deviations, performing formal root cause analysis, and defining effective corrective and preventive actionsDESCRIPTION DE LA MISSION:...

  • Therapy Lead Glp-1 Marketing Diabetes

    vor 2 Wochen

    Freiburg, Freiburg, Schweiz Novo Nordisk Vollzeit

    Therapy Lead GLP-1 Marketing DiabetesCategory:Commercial MarketingLocation:Zurich, Switzerland Zurich, CH- Join our dynamic team as we seek a visionary Marketing Strategist- Are you ready to drive innovation and shape the future of marketing? We're seeking a talented individual who will lead our marketing efforts to new heights.The position In this exciting...