Process Expert DP (m/f/d)

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 compagny 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 compagny 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!