Aktuelle Jobs im Zusammenhang mit Process Engineering Lead, Drug Product External Manufacturing Operations - Bern - CSL Behring AG

  • Process Engineering Lead, Drug Product External Manufacturing Operations

    vor 1 Woche

    Bern, Schweiz CSL Behring Vollzeit

    As a Drug Product (DP) External Manufacturing Lead you will be responsible for providing process engineering support for all DP manufacturing conducted on behalf of CSL Behring Operations at contract manufacturing organizations (CMOs). You will be accountable for establishing and managing key process performance indicators across multiple CMOs, products and...

  • Process Engineering Lead, Drug Product External

    vor 2 Monaten

    Bern, Schweiz CSL Behring Vollzeit

    This role requires significant international travel. **Responsibilities**: - Lead transition of technical oversight from project (tech transfer) to operations phases for DP external manufacturing - Ensure that key parameters for process monitoring are identified and charts (e.g. time series, control charts) are set up and maintained - Ensure key process...

  • Process Engineering Lead, Drug Product External

    vor 2 Monaten

    Bern, Schweiz CSL Behring Vollzeit

    This role requires significant international travel. **Responsibilities**: - Lead transition of technical oversight from project (tech transfer) to operations phases for DP external manufacturing - Ensure that key parameters for process monitoring are identified and charts (e.g. time series, control charts) are set up and maintained - Ensure key process...

  • External Manufacturing Manager

    vor 2 Wochen

    Bern, Schweiz Proclinical Group Vollzeit

    Proclinical is partnered with a prestigious global biotechnology company that is seeking an accountable and results-driven External Manufacturing Manager to become an integral part of their dynamic team based in Belgium. This permanent role offers the opportunity to lead the operational oversight of global Contract Manufacturers and strategic vendors,...

  • Engineer Manufacturing Science Drug Product

    vor 1 Monat

    Bern, Schweiz Randstad (Schweiz) AG Vollzeit

    JobdescriptionCaring for the world, one 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...

  • Engineer Manufacturing Science Drug Product

    vor 2 Monaten

    Bern, Schweiz Randstad - Medium prio Vollzeit

    JobdescriptionCaring for the world, one 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...

  • Manufacturing Sciences Upstream Process Technology

    vor 5 Monaten

    Bern, Schweiz Recrutis Vollzeit

    For one of our clients, a leading Worldwide Biotech company in Bern area, we are currently looking for a **Manufacturing Sciences Upstream Process Technology Lead** **_ JOB PURPOSE:_** As a key leader in Upstream Process Technologies you join the Global Manufacturing Sciences Department at the Drug Substance biologics manufacturing site to oversee all USP...

  • Lead Technician Gmp Operations

    vor 4 Wochen

    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...

  • External Supply Integration Sr. Manager

    vor 1 Monat

    Bern, Schweiz CSL Behring Vollzeit

    As the _External Supply Integration Sr. Manager _- EMEA _at CSL Behring, you will ensure our external operations within the EMEA region align with our growth aspirations and maintain supply integrity. This role involves establishing operational capabilities through outsourcing and external supply networks. You will develop strategies, build essential...

  • Sr Manager Gmp Operations

    vor 5 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 5 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...

  • Cmc Lead Plasma Products Development

    vor 5 Monaten

    Bern, Schweiz We make it GmbH Vollzeit

    We make it GmbH is a nationally active company in Switzerland with a high level of expertise in the field of personnel services thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We at it GmbH set the highest standards for...

  • Manager, Quality Engineering Methods Transfer

    vor 5 Monaten

    Bern, Schweiz CSL Behring Vollzeit

    **The Opportunity** Reporting into the Quality Engineering Methods Transfer & Stability Leader, the Methods Transfer & Stability Manager will provide QA oversight for projects covering methods transfer & stability. The individual will partner with the process and product owners of Capex projects at the Bern manufacturing site and will support QA oversight...

  • Sr Team Leader Dsp Gmp Operations

    vor 5 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...

  • Head of Manufacturing, Villeret

    vor 5 Monaten

    Bern, Schweiz Straumann Group Vollzeit

    The Head of Manufacturing at the Villeret Straumann production site is responsible for overseeing all production departments. As a first step she/he will take charge of the finishing department (350 talents), including surface treatment, assembly operations, visual inspections, and packaging, with a flow-oriented approach. This first stage will allow her/him...

  • Assoc Manager Usp Gmp Operations

    vor 4 Wochen

    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...

  • Manufacturing Science Engineer

    vor 1 Monat

    Bern, Bern, Schweiz Randstad - Medium prio Vollzeit

    About the JobCaring for the world, one 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 healthcare to touch the lives of over a...

  • Msat Scientist

    vor 6 Monaten

    Bern, Schweiz Johnson & Johnson Vollzeit

    **MSAT Scientist**: Johnson and Johnson is recruiting for a **Manufacturing Science and Technology **(MSAT) **Scientist, **preferably located in **Bern, Switzerland **or **Leiden, The Netherlands **. The Scientist we are looking for is responsible for supporting tech transfer activities and technical services across the platform of the Advanced Therapies....

  • Lead Technician Gmp Operations

    vor 5 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...

  • MSIT Engineer

    vor 1 Monat

    Bern, Bern, Schweiz Randstad - Medium prio Vollzeit

    Job DescriptionWe are seeking a highly skilled MSIT Engineer to join our team in Bern, Switzerland. As a key member of our Manufacturing Science Innovation & Technology team, you will be responsible for executing project activities in different areas of biopharmaceutical processes in the Late Stage Development department.Main ResponsibilitiesYou will be...

Process Engineering Lead, Drug Product External Manufacturing Operations

vor 2 Monaten

Bern, Schweiz CSL Behring AG Vollzeit

As a Drug Product (DP) External Manufacturing Lead you will be responsible for providing process engineering support for all DP manufacturing conducted on behalf of CSL Behring Operations at contract manufacturing organizations (CMOs). You will be accountable for establishing and managing key process performance indicators across multiple CMOs, products and geographies, driving yield/performance improvements, supporting deviation investigations related to process robustness and associated corrective action/preventative action (CAPA). You will also ensure the application of engineering and scientific knowledge to support all DPs in routine operations at CMOs, primarily in Europe and sometimes North America.

 

This role requires significant international travel.

 

Responsibilities:

  • Lead transition of technical oversight from project (tech transfer) to operations phases for DP external manufacturing
  • Ensure that key parameters for process monitoring are identified and charts (e.g. time series, control charts) are set up and maintained
  • Ensure key process and asset attributes relevant to reducing variability are tracked, increasing performance of the process and visualizing in reporting
  • Evaluate long-term trends, maintain log of loss drivers (e.g. performance, availability and quality losses), identify improvement levers, and plan robustness and continuous improvement initiatives
  • Support deviations linked to process robustness, train and coach others on how to interpret robustness trends, actively liaise with other functions to identify loss drivers, including aseptic process/technology owner, QA specialist and broader Global Engineering
  • Participate in cross-functional, external plant operations teams, act as single point of contact (SPOC) for Engineering in such teams, engage broader organization to drive problem solving capability and lead investigations through the use of problem-solving tools
  • Provide technical person in plant (PIP) support for routine CMO operations as required and in conjunction with Quality PIP. Represent CSL Behring at technical interface with CMO partners
  • The position doesn't include direct reports

 

Qualifications & Experience:

  • University degree in engineering or science; higher degree preferred
  • Aseptic/sterile processing and visual inspection of biopharmaceuticals in one or more of Operations, Process Engineering or Quality Assurance (5+ years post graduate experience)
  • Fluency in German and English
  • Experience in GMP, problem solving, continuous improvement, vendor relationships, data analysis & interpretation

 

Additional Comments:

This is a matrix leadership role working with internal and external partners to deliver reliable, efficient, on-time performance from the CMO network for DP manufacture. As such, the ability to work across national and cultural boundaries, honed analytical skills, detailed planning, and interpersonal savvy to achieve partner buy-in for strategies and plans will be essential for success. An ability to resolve routine issues at point whilst maintaining an acumen for stakeholder management and escalation of topics impacting product supply, multimillion dollar provisions or patient safety will also be required.