Senior Expert, Science & Technology (EPM Specialist)

Major accountabilities:

Owning and leading process improvement activities related to externalized process R&D Supporting oversight / documentation / workflows related to externalized business (non-GMP/GMP). Managing data and readouts related to externalized activities (compilation of relevant KPIs for regular evaluations with external partners) Supporting CMC document writing and regulatory submissions Contributing to evaluation, selection and onboarding process of new external partners.

Actively managing interactions between internal and external partners to ensure a constructive and well-functioning collaboration. Participating in scientific/technical exchange with internal stakeholders and external partners. Supervising GMP activities such as master batch record and executed batch record handling, deviation handling and change control management. Support external manufacture and timely delivery of drug substance. Reviewing technical and GPM-relevant documents. Identifies and supports continuous improvement initiatives related to external partners and internal processes. Supporting/leading set up of data bases and document flow process within the EPM unit. Owning, developing and maintaining team SharePoint.

What you ll bring to the role:

Desirable: PhD/MSc in chemistry, chemical engineering or equivalent and a minimum 3 years experience in the pharmaceutical industry in chemical development and/or commercial. Proven experience in a GMP environment (equipment/facilities, manufacturing, deviation handling, change control, documentation etc.) Successfully demonstrated expertise in a specific scientific/technical area. Fluent English (oral and written). Strong coordination and communication skills, collaborative spirit, self-driven attitude, high level of learning agility are key attitudes.

Excellent knowledge of data management and software/tools such as Office package (e.g. Excel, SharePoint, MSTeams), SAP, planning tools etc.
Personal inclination for IT solutions and data management is a plus. Experience in operational excellence and Six Sigma certification is a plus. Experience and knowledge in procurement of API, intermediates, raw materials and services incl. management of RFPs and RFIs is a plus.