Process Engineering Lead, Drug Product External Manufacturing Operations
vor 2 Monaten
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.
Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring-
Bern, Schweiz CSL Behring AG VollzeitAs 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...
-
Bern, Schweiz CSL Behring AG VollzeitAs 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...
-
Bern, Schweiz CSL Behring AG VollzeitAs 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...
-
Bern, Schweiz CSL Behring AG VollzeitAs 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...
-
Bern, Bern, Schweiz CSL Behring VollzeitJob SummaryWe are seeking a highly skilled Process Engineering Lead to join our team at CSL Behring. As a key member of our External Manufacturing Operations team, you will be responsible for providing process engineering support for all Drug Product manufacturing conducted on behalf of CSL Behring Operations at contract manufacturing organizations...
-
Bern, Schweiz CSL Behring VollzeitAs 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...
-
Bern, Schweiz CSL Behring VollzeitAs 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...
-
Bern, Bern, Schweiz CSL Behring AG VollzeitJob SummaryWe are seeking a highly skilled Process Engineering Lead to join our team at CSL Behring AG. As a key member of our External Manufacturing Operations team, you will be responsible for providing process engineering support for all Drug Product manufacturing conducted on behalf of CSL Behring Operations at contract manufacturing organizations...
-
Bern, Bern, Schweiz CSL Behring AG Vollzeit{"title": "Process Engineering Lead, Drug Product External Manufacturing Operations", "description": "Job SummaryAs a Process Engineering Lead, you will be responsible for providing process engineering support for all Drug Product (DP) manufacturing conducted on behalf of CSL Behring Operations at contract manufacturing organizations (CMOs). You will be...
-
Bern, Bern, Schweiz CSL Behring VollzeitJob SummaryWe are seeking a highly skilled Process Engineering Lead to join our team at CSL Behring. As a key member of our External Manufacturing Operations team, you will be responsible for providing process engineering support for all Drug Product manufacturing conducted on behalf of CSL Behring Operations at contract manufacturing organizations...
-
Bern, Bern, Schweiz CSL Behring VollzeitJob SummaryWe are seeking a highly skilled Process Engineering Lead to join our team at CSL Behring. As a key member of our External Manufacturing Operations team, you will be responsible for providing process engineering support for all Drug Product manufacturing conducted on behalf of CSL Behring Operations at contract manufacturing organizations...
-
Bern, Bern, Schweiz CSL Behring VollzeitJob SummaryWe are seeking a highly skilled Process Engineering Lead to join our team at CSL Behring. As a key member of our External Manufacturing Operations team, you will be responsible for providing process engineering support for all Drug Product manufacturing conducted on behalf of CSL Behring Operations at contract manufacturing organizations...
-
Bern, Bern, Schweiz CSL Behring VollzeitJob SummaryWe are seeking a highly skilled Process Engineering Lead to join our team at CSL Behring. As a key member of our External Manufacturing Operations team, you will be responsible for providing process engineering support for all Drug Product manufacturing conducted on behalf of CSL Behring Operations at contract manufacturing organizations...
-
Bern, Bern, Schweiz CSL Behring AG VollzeitAs a Process Engineering Lead for External Manufacturing Operations, you will be responsible for providing process engineering support for all Drug Product 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...
-
Process Engineering Lead, Drug Product External
vor 2 Monaten
Bern, Schweiz CSL Behring VollzeitThis 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 VollzeitThis 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 Tagen
Bern, Schweiz Proclinical Group VollzeitProclinical 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 4 Wochen
Bern, Schweiz Randstad (Schweiz) AG VollzeitJobdescriptionCaring 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 1 Monat
Bern, Schweiz Randstad - Medium prio VollzeitJobdescriptionCaring 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 VollzeitFor 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...
