Senior Lead External Manufacturing – Drug Product Fill & Finish
In 13 years, the EFOR Group has reached the leading position in Life Sciences consulting with strong, synergic and strategic acquisitions.
Our ambition is to build a global leading position of our market in 2028.
Today, we are an innovative organization working with passionate specialists and committed consultants according to our three values: Commitment, Excellence and Sharing.
In Switzerland, we work with 300 experts who support our customers on their various projects in the French- and German-speaking parts. We help our customers to diversify and to grow through the work of our consultants and the technical expertise of our Solution & Project Delivery Department.
To strengthen our team in Schaffhausen we are looking for a Senior Lead External Manufacturing – Drug Product Fill & Finish
About the Role
We are seeking an experienced Senior Lead External Manufacturing – Drug Product Fill & Finish to support the technical transfer of Drug Product manufacturing processes from clinical development into scalable and commercially viable manufacturing operations.
In this role, you will work closely with internal development teams and external CMOs/CDMOs , ensuring that manufacturing processes are successfully transferred, scaled up, and prepared for future commercial production.
A key focus of this position is Technology Transfer, Scale-up, and collaboration with external manufacturing partners within Drug Product and Fill & Finish operations.
Key Responsibilities
- Ensure the timely readiness of external Contract Manufacturing Organizations (CMOs/CDMOs) and internal pilot plants to support clinical programs.
- Ensure the timely manufacturing and delivery of clinical materials through internal and external manufacturing partners.
- Act as the primary point of contact and interface between internal stakeholders and external manufacturing sites.
- Collaborate closely with Drug Product Development and Primary Container Development teams to define technical requirements and manufacturing strategies.
- Plan, coordinate, and support technology transfer and scale-up activities .
- Ensure manufacturing processes are robust, reproducible, scalable, and suitable for transfer into larger-scale or commercial manufacturing environments.
- Support Drug Product and Fill & Finish processes with respect to scalability, transferability, and commercial feasibility.
- Manage the sourcing of raw materials and components and coordinate supplier- and material-related topics with CMOs.
- Support investigations, deviations, CAPAs, and change controls, including the review of critical GMP documentation and raw data.
- Identify opportunities for process optimization and drive continuous improvement initiatives.
- Monitor project costs, forecasts, and budgets related to external manufacturing activities.
Your Profile
- Bachelor's, Master's, or PhD degree in Pharmacy, Chemistry, Chemical Engineering, Biotechnology, Life Sciences , or a related discipline.
- Several years of experience in one or more of the following areas:
- MSAT (Manufacturing Science & Technology)
- Drug Product Manufacturing
- Fill & Finish
- Technical Operations
- Process Development
- External Manufacturing
- Proven experience in technology transfer and scale-up projects .
- Experience working with CMOs/CDMOs .
- Strong understanding of GMP requirements, process validation, deviations, CAPAs, and change control processes.
- Excellent communication and stakeholder management skills.
- Fluent English required; German language skills are highly preferred.
This is an on-site role.
Only applicants with Swiss or EU/EFTA citizenship or candidates with an existing and valid residence and work permit in Switzerland will be considered.
Do you want to join a dynamic and ambitious company? EFOR is made for you.
#J-18808-Ljbffr
MSAT Expert - Drug Product, Fill Finish & Tech Transfer in Schaffhausen Arbeitgeber: EFOR
Die EFOR Group ist ein hervorragender Arbeitgeber, der in der dynamischen Umgebung von Visp eine innovative und unterstützende Arbeitskultur bietet. Mit einem starken Fokus auf Engagement, Exzellenz und Wissensaustausch fördert das Unternehmen die persönliche und berufliche Weiterentwicklung seiner Mitarbeiter und bietet zahlreiche Möglichkeiten zur Zusammenarbeit an spannenden Projekten im Bereich Life Sciences. Die Mitarbeitenden profitieren von einem inspirierenden Team aus Experten und einer klaren Vision für die Zukunft, was die EFOR Group zu einem attraktiven Arbeitsplatz macht.
