Brussels Metropolitan Area
As Head of CMC Dev Outsourcing Operations, I am responsible for the selection, business relationship & contract management for external partners involved in CMC Dev (NCE, NBE and Gene Therapy) as well as Devices & Packaging related process & analytical development activities.
Management of external activities in the areas of both DS and DP development activities (process R&D and toll manufacture from lab to pilot and plant scale) • Management of a external network of (potential) partners covering the whole range of activities related to DS and DP development activities. • Involvement in the choice of preferred or strategic external partners and management of the on-going partnerships. • Organization and active involvement in on-site visits & (QA) audits. • Appropriate support given to UCB Procurement, Legal and IP departments in the set-up of Contracts / Services Agreements. • Comprehensive evaluation of the technical activity to be externalized. • Full involvement in the preparation of high quality technical documents (e.g. RFQ, Tech Transfer). • Detailed assessment of quotes and active participation in the choice of the most appropriate partner. • Initiation and follow up of technical activities in order to facilitate the interaction and communication between CPD teams and the external partners: contact matrix, planning, management of TCs, ... This also includes the follow-up of KPIs tables. • Adequate technical support and advices given to external partners to meet deliveries and timelines. Continuous assessment of priorities and modification of external resources as needed. • Follow-up of all deliveries, ensuring they are in time and meeting the quality and quantity target (product, reports and other relevant information like analytical data, analytical methods, CoA, …). • Adequate follow-up of invoice payments and tracking of expenses, ensuring full alignment of actual costs with the agreed budget. • Implementation of a robust system and process for the outsourcing of technical activities (DS, DP and Analytics). This also includes a comprehensive Guideline and set of tools and templates supporting the outsourcing process.
External Partnership Management Management of external activities in the areas of DS process R&D and toll manufacture from lab to pilot and plant scale. Management of a external network of (potential) partners covering the whole range of activities related to DS development activities as well as related to the supply of Clinical Trials materials.
Management of route selection & process research activities in order to identify and develop industrially viable processes for new drug candidates in the UCB Pharma portfolio in addition to obtaining patent protection for novel process development activity. Responsible for effective planning, initiation and project management of the production of laboratory or pilot batches in order to provide DS for CPD&I clients – for use in clinical trials and pharmaceutical development studies.
Responsible for and coordination of route selection & process research activities to identify and develop industrially viable processes for drug candidates. Responsible for the development and optimization of efficient process at laboratory scale, with subsequent demonstration and validation at pilot scale as a prelude to transfer to a production scale. Organization and supervision of the production of laboratory or pilot batches in order to provide DS for toxicology, clinical trials and pharmaceutical development studies.
Management of the Chemical Process Control laboratory aimed at performing “in process control” analyses for both DS Production and Chemical Development Department. Active involvement in solving process issues in Production (troubleshooting). Development and validation of new analytical methods.
Synthesis of new alpha-substituted acrylic derivatives. (co)-polymerization of new monomers synthesized and evaluation of properties and reactivity of the (co)-polymers obtained.