Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Your role The MSAT DP leads and manages all the Drug Products site technical activities within the company site to ensure the business continuity and Product-Lifecycle activities on legacy products portfolio, in compliance with specifications, registration and GMP requirements. Evolving in this environment, DP Process Expert role is:
To roll out and being DP process key contact point with the project stakeholders during the site activities for new product introductions (NPIs), technology transfer (TT), validation of Drug Product (DP) process or new product or process changes for commercial products.
To ensure coordination of projects and production falling under the responsibility of DP MSAT and as agreed with the site Project Manager (SPM) or DP expert Associate Manager.
ACCOUNTABILITY AREA Technical transfer / commercial manufacturing campaign activities coordination
As part of DP process expert team, coordinate Process improvement for large scale manufacturing for multi-product projects (impacting different molecules).
Implementation of new technologies, PAT
Contribute to product strategy elaboration in collaboration with Site Project Manager (SPM) or DP expert Associate Manager and other departments
Assure the timely delivery of required documents (strategy plans, protocols and reports,...) as defined in the project plan
Establish relevant change control proposals related to the projects (single or multi-site) with Site Project Manager (SPM) or DP expert Associate Manager
To ensure appropriate documentation and data management using corresponding IT system, including QMS softwares (TrackWise, ManGo), ERP (SAP)...
Coordination of production troubleshooting/investigation and potential support, if required
Ensure that all process support activities are carried out at appropriate compliance levels
Contribute and review the commercial product review document or campaign reports
Leads major investigations in close collaboration with the DP expert Associate Manager & SPM & Validation expert, production and quality unit as well as pharma development when required
Coordination with Pharmaceutical Development entities
Ensure that due consideration is given to manufacturing requirements and potential issues as early as possible during the development of a process to be transferred and/or validated in production
Training of the company personnel
Provide training for new processes implementation, the Tech Transfer or new technology strategy
Provide DP process expertise/innovation and enrich the current platform knowledge
Internal / External audits
Ensure that above activities are auditable anytime
Participate to internal/external audits
Who you are
Degree in Biotechnology, Process Engineering, Pharmacy or related subject.
Experience in Drug product manufacturing
Experience in R&D/Manufacturing environment (> 5 years).
Experience in coordination of activities
Experience in Extractable & Leachable, chemical compatibility, filter validation
Sound awareness of bio-pharmaceutical business
Sound awareness of GMP related issues and Health Authorities' requirements
Demonstrated success record in process improvements
Demonstrated success record in position which interacts with other departments
Must master and demonstrate ability to work in agile environment
Fluent in French and English
What we offer We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
#J-18808-Ljbffr
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Your role The MSAT DP leads and manages all the Drug Products site technical activities within the company site to ensure the business continuity and Product-Lifecycle activities on legacy products portfolio, in compliance with specifications, registration and GMP requirements. Evolving in this environment, DP Process Expert role is:
To roll out and being DP process key contact point with the project stakeholders during the site activities for new product introductions (NPIs), technology transfer (TT), validation of Drug Product (DP) process or new product or process changes for commercial products.
To ensure coordination of projects and production falling under the responsibility of DP MSAT and as agreed with the site Project Manager (SPM) or DP expert Associate Manager.
ACCOUNTABILITY AREA Technical transfer / commercial manufacturing campaign activities coordination
As part of DP process expert team, coordinate Process improvement for large scale manufacturing for multi-product projects (impacting different molecules).
Implementation of new technologies, PAT
Contribute to product strategy elaboration in collaboration with Site Project Manager (SPM) or DP expert Associate Manager and other departments
Assure the timely delivery of required documents (strategy plans, protocols and reports,...) as defined in the project plan
Establish relevant change control proposals related to the projects (single or multi-site) with Site Project Manager (SPM) or DP expert Associate Manager
To ensure appropriate documentation and data management using corresponding IT system, including QMS softwares (TrackWise, ManGo), ERP (SAP)...
Coordination of production troubleshooting/investigation and potential support, if required
Ensure that all process support activities are carried out at appropriate compliance levels
Contribute and review the commercial product review document or campaign reports
Leads major investigations in close collaboration with the DP expert Associate Manager & SPM & Validation expert, production and quality unit as well as pharma development when required
Coordination with Pharmaceutical Development entities
Ensure that due consideration is given to manufacturing requirements and potential issues as early as possible during the development of a process to be transferred and/or validated in production
Training of the company personnel
Provide training for new processes implementation, the Tech Transfer or new technology strategy
Provide DP process expertise/innovation and enrich the current platform knowledge
Internal / External audits
Ensure that above activities are auditable anytime
Participate to internal/external audits
Who you are
Degree in Biotechnology, Process Engineering, Pharmacy or related subject.
Experience in Drug product manufacturing
Experience in R&D/Manufacturing environment (> 5 years).
Experience in coordination of activities
Experience in Extractable & Leachable, chemical compatibility, filter validation
Sound awareness of bio-pharmaceutical business
Sound awareness of GMP related issues and Health Authorities' requirements
Demonstrated success record in process improvements
Demonstrated success record in position which interacts with other departments
Must master and demonstrate ability to work in agile environment
Fluent in French and English
What we offer We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
#J-18808-Ljbffr
Process Expert DP (m/f/d) Arbeitgeber: Merck
Als Arbeitgeber im Gesundheitswesen bieten wir Ihnen die Möglichkeit, Teil eines dynamischen und innovativen Teams zu werden, das sich leidenschaftlich für die Verbesserung von Leben einsetzt. Unsere inklusive und flexible Unternehmenskultur fördert persönliches Wachstum und Karrierechancen auf globaler Ebene, während wir gemeinsam an bahnbrechenden Lösungen in der Gesundheitsversorgung arbeiten. Bei uns haben Sie die Chance, Ihre Fähigkeiten in einem unterstützenden Umfeld weiterzuentwickeln und einen echten Unterschied im Leben von Patienten zu machen.
