Assoc Manager Usp Gmp Operations

vor 2 Monaten

Bern, Schweiz Johnson & Johnson Vollzeit

Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.

Assoc ManAger USP GMP Operations (M/F/D)

(Ref: 2406221161W)

YOUR responsibilities & YOUR impact:
Aim of this role
- Leading and developing the USP 2x10L Lenti Operations team within GMP Operations which includes all manufacturing related activities from pre-clinical to commercial product supplies

General Activities
- Supervises personnel, and equipment of the team to meet project demands
- Hires, motivates, develops, and mentors staff to provide employee growth within the team and fosters a culture of continuous improvement
- Timely delivery of product or intermediate product of the correct quality and quantity to meet project demands.
- Give input to and follow up on departmental goals.
- Management of team and responsible for the development of staff, performance of appraisals and have key role in recruitment of new hires.
- Provide input in setting the annual departmental budget.
- Define team objectives, translate them into activities and take responsibility for the overall results of those activities.
- Supports technology transfer within the Development organization and cross functional with supply chain.
- Assures that data from GMP manufacturing & Development activities is prepared, analyzed, interpreted and retained accurately
- Write, review and approve Study Plans & Study Reports.
- Key role in writing study plans, study reports, MBRs, SOPs
- Assure that the members of the team keep up to date with developments in own field and are adequately trained; represent own expertise field within and outside Janssen.
- Participates as the USP production Subject Matter Expert in regulatory inspections and is experienced with the required GMP and regulatory guidelines.
- Maintain and continuously improve cGMP compliance within USP area; support maintenance and improvement of cGMP compliance within the facility with relation to USP area.
- Documentation management according to predefined responsibilities (author -reviewer or approver)
- Communication with internal and external parties for raw material supply as well as for purchasing and commissioning of new equipment
- Supporting the TS C&Q organization to assure that all equipment, rooms, and utilities are qualified for purpose
- Supporting the MSIT Validation organization to assure that all processes are validated for purpose
- Collaboration with other departments across VPAD Bern and VPAD Leiden and DPDS departments and external stakeholders
- Support of LEAN implementation and continuous improvement projects
- Active participation in the improvement of cGMP compliance, process excellence and process development aspects of CTM manufacturing
- The Sr Team Leader is the deputy for the Manager of GMP Operations for their related departmental topics
- 2x 10 L USP team members

**Qualifications**:
We would love to hear from YOU, if you have:
Essential
- MSc or bachelor's dree in life sciences with 5-10 years of relevant experience in CMC development, manufacturing of Parmaceutical products
- Knowledge and experience of cGMP manufacturing of CTM and/or commercial drug product
- Knowledge of USP technology/viral processes and aseptic processing

Key competencies required
- SME experience in USP area including pilot scale and technology transfer
- Several years of experience with leading teams
- Advanced knowledge of goal setting, leadership, problem solving, communication, mentoring and coaching techniques
- Knowledge and interpretation/implementation ability of cGMP and current Regulatory Compliance Guidelines
- Fluency in English and German preferred

This is what awaits YOU at J&J:

- An opportunity to be part of a global market leader.
- A dynamic and inspiring working environment.
- Many opportunities to work on challenging projects and assignments.
- Possibilities for further personal as well as professional development.
- Many employees benefits.

  • Sr Team Leader Usp Gmp Operations

    vor 6 Monaten

    Bern, Schweiz Johnson & Johnson Vollzeit

    "Caring for the worldone person at a time”inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people...

  • Sr Manager Gmp Operations

    vor 6 Monaten

    Bern, Schweiz Johnson & Johnson Vollzeit

    "Caring for the worldone person at a time”inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people...

  • Sr Manager Gmp Operations

    vor 6 Monaten

    Bern, Schweiz Johnson & Johnson Vollzeit

    "Caring for the worldone person at a time”inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people...

  • Lead Technician Gmp Operations

    vor 6 Monaten

    Bern, Schweiz Johnson & Johnson Vollzeit

    Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure...

  • Lead Technician Gmp Operations

    vor 2 Monaten

    Bern, Schweiz Johnson & Johnson Vollzeit

    Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure...

  • Sr Technician Usp

    vor 6 Monaten

    Bern, Schweiz Johnson & Johnson Vollzeit

    Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure...

  • Sr Techician Gmp Operations

    vor 6 Monaten

    Bern, Schweiz Johnson & Johnson Vollzeit

    Senior Technician GMP Operations (Fill and Finish) **Zu den Haupttätigkeiten gehören unter anderem**: - Praktische Durchführung der Fill&Finish Entwicklungs - und Produktionsarbeit (Experimente, Produktionen und Tests) unter Leitung von Teamleader/Stellvertreter und gemäss geltenden Vorschriften (cGMP, SOP, MBR) - Mitwirkung bei der Herstellung von...

  • Quality Assurance Operations Specialist

    vor 3 Wochen

    Bern, Bern, Schweiz Gi Life Sciences Vollzeit

    For a leading biotechnology company, Gi Life Sciences is seeking an experienced Quality Assurance Operations Specialist to support the operational readiness of new product introductions.The ideal candidate will have experience in a similar position within a GMP environment and possess strong analytical skills, with a keen eye for detail. Proficiency in...

  • Sr Team Leader Dsp Gmp Operations

    vor 6 Monaten

    Bern, Schweiz Johnson & Johnson Vollzeit

    "Caring for the worldone person at a time”inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people...

  • Quality Assurance Specialist for Biotech Manufacturing

    vor 3 Wochen

    Bern, Bern, Schweiz Gi Life Sciences Vollzeit

    Job DescriptionGi Life Sciences is seeking a highly skilled Quality Assurance Specialist to support the operational readiness of new product introduction in our biotechnology industry.Responsibilities:Ensure daily compliance with USP and DSP manufacturing area standards, including KPI monitoring.Schedule and manage daily operational activities, such as...

  • Manager Product Quality

    vor 3 Monaten

    Bern, Schweiz Johnson & Johnson Vollzeit

    Janssen Vaccines, Branch of Cilag International GmbH, a member of the Johnson & Johnson Family of Companies is recruiting for an Manager Product Quality, located in Bern, Switzerland. The Product Quality Manager is responsible for ensuring that activities related to product manufacturing are compliant with applicable GMP requirements. With his / her team,...

  • Event Operations Manager

    vor 6 Monaten

    Bern, Schweiz PermServ AG Vollzeit

    Zurück zur Übersicht PermServ AG verbindet Menschen und Unternehmen. Die Erfahrung und Kompetenz unserer Consultants garantieren Ihnen eine exzellente, schnelle und individuelle Dienstleistung. Wir begleiten und betreuen Sie auf dem Weg zu Ihrem beruflichen Ziel. Für unseren Kunden, ein Betrieb eingebettet in der schönen Natur mit vielfältigem...

  • Quality Assurance Manager for Pharmaceutical Operations

    vor 3 Wochen

    Bern, Bern, Schweiz CSL Behring AG Vollzeit

    We are seeking an experienced Quality Assurance Manager to join our team at CSL Behring AG. This role will partner closely with Global Quality Systems and other Quality functions to continuously improve and standardize quality processes and standards across the network.About this RoleThis is a full-time opportunity where you will be responsible for leading...

  • Responsable de la Qualité dans un Environnement GMP

    vor 3 Wochen

    Bern, Bern, Schweiz Gi Life Sciences Vollzeit

    Gi Life Sciences, une entreprise leader dans le domaine de la biotechnologie, recherche un professionnel expérimenté pour occuper le poste de responsable de la qualité.SalaireNous offrons un salaire compétitif, estimé à environ 60 000 euros par an, en fonction des qualifications et de l'expérience.Déscription du posteVous serez chargé de soutenir la...

  • QA operational

    vor 3 Wochen

    Bern, Schweiz Gi Life Sciences Vollzeit

    For our partner in biotechnology industry, Gi Life Science is looking for:QA operational(temporary position)Your mission: Support operational readiness of new product introductionYour responsibilities: Responsible for the daily support of the manufacturing area (USP and DSP), including compliance, KPI,Schedule daily operational activities e.g. material...

  • Manufacturing Engineer

    vor 2 Wochen

    Bern, Schweiz Gi Life Sciences Vollzeit

    For our partner in biotechnology industry, Gi Life Science is looking for:Manufacturing Engineer(temporary position)Your mission: Support operational readiness of new product introductionYour responsibilities: Responsible for the daily support of the manufacturing area (USP and DSP), including compliance, KPI,Schedule daily operational activities e.g....

  • Fachexperte für Mikrobiologische Qualitätskontrolle

    vor 4 Wochen

    Bern, Bern, Schweiz CSL Behring AG Vollzeit

    JobbeschreibungBeschreiben Sie die tägliche Arbeit als Senior Scientific Expert in der mikrobiologischen Qualitätskontrolle.Fachtechnische Betreuung der Laborgruppe und Sicherstellung der GMP Compliance.Auswertung von Testergebnissen und Qualitätssicherung von mikrobiologischen Geräten.Hier ist ein Überblick über die...

  • Qa Operational

    vor 4 Wochen

    Bern, Schweiz Gi Life Sciences Vollzeit

    For our partner in biotechnology industry, Gi Life Science is looking for: QA operational(temporary position) Your mission: Support operational readiness of new product introduction Your responsibilities: Responsible for the daily support of the manufacturing area (USP and DSP), including compliance, KPI,Schedule daily operational activities e.g. material...

  • Qa Operational

    vor 1 Monat

    Bern, Schweiz Gi Life Sciences Vollzeit

    For our partner in biotechnology industry, Gi Life Science is looking for: QA operational(temporary position) Your mission: Support operational readiness of new product introduction Your responsibilities: Responsible for the daily support of the manufacturing area (USP and DSP), including compliance, KPI,Schedule daily operational activities e.g. material...

  • Process Engineer

    Vor 7 Tagen

    Bern, Schweiz Gi Life Sciences Vollzeit

    For our partner in the canton of Berne, Gi Life Sciences is looking for a:Process Engineer(temporary mission - extendable)Responsibilities:Provide support and troubleshooting in Drug Substance Manufacturing areas like USP, DSP, and Solution Preparation.Oversee as process owner equipment installation, maintenance, and calibration, ensuring top performance and...