Beuningen, Gelderland, Netherlands
I am a motivated and results-driven professional with a M.Sc. in Chemistry and extensive experience in the vaccine and small molecules pharmaceutical industry as a portfolio & project manager. Leading interdisciplinary approach in combination C(D)MO's, contract labs and CRO's. I possess a diverse skill set that includes coaching, portfolio management, project management, business & project integration, process management, quality assurance, regulatory affairs, operations, technology transfers, logistics, facilities, finance, and ICT PPM tools. I am seeking a challenging role as a (Senior) Project Manager, CMC lead, (QC) Laboratory manager or business excellence officer, where I can utilize my expertise to drive successful project outcomes, contribute to the overall growth and success of the organization and deployment of staff.
Bridging operations, project management and finances by professionalizing processes, procedures and collaboration by working smarter (within project) using Microsoft 365 tools Bridging operations, project management and finances by professionalizing processes, procedures and collaboration by working smarter (within project) using Microsoft 365 tools like Project for the Web, Teams, Power BI and connecting with ERP/SAP to prepare for the next level of (E)PPM. Technology supported by JSR consultancy. Main targets to professionalize the way of working and collaboration in projects and groups, develop a portfolio planning tool to create valuable insight in effectivity, efficiency and resources.
Responsible portfolio of Intravacc, participation in new leads by Business development, new and active projects by clients and own product & platform development, including client account management. Lead for Portfolio board and member of Management Team. Leading a team of project & account managers. Requires an interdisciplinary approach in combination C(D)MO's, contract labs and CRO's. In this position, member of the Management Team of Intravacc. Intravacc bridge vaccine development from discovery to pilot-scale GMP biomanufacturing. Intravacc offers a one-stop shop for independent vaccine development, from discovery to pilot production, including CMC, to clinical studies phase 1 (FIH).
Primary: Portfolio management of Swine vaccine products covering new vaccines from R&D to Manufacturing division. Monitoring success of in-line products with respect to batch success rate, (process) rejects and process & assay capability. Identify product, process and assay improvements, and subsequently initiate investigations and changes supported by business cases. Stakeholders: R&D, Value/supply chain, Manufacturing, RA, QA/QC, Marketing Secondary: Define and introduce three steward roles; Product, Technical and Platform Steward. Identify and align with stakeholders in the organisation. Support steward in being effective and efficient in the role. Develop and introduce (digi-)product dashboard to support monitoring and quick identification of risks and issues. Cooperation with the Innovation group Starting to introduce CPP and CQA of in-line products to improve process capability and support effective change and event control. Cooperation with Manufacturing division and Innovation group
Line- and process manager of the project organization of Intravacc, including program managers, project leads, project office and, as interim, business managers. Including contracting C(D)MO's, contract labs and CRO's. In this position, member of the Management Team of Intravacc. Intravacc, with VWS as owner, will be transferred to an independent company. As a result, it is required to be self-supporting and with that the organization will change from a R&D to project and result orientated. In this the task: - To support actively the change and implement processes and tools to improve project management - To actively support business approach improvements to be able to assess viability of products before starting product development & CMC. - Develop and introduce a vaccine development pathway. Based on TB Vaccine development pathway (www.tbvacpathway.org) and adapted to Intravacc scope. Requires interdisciplinaire approach with operations, program managment, legal, finance and management team.
Position corresponding to CMC lead including (Pre-)Clinical and account management. Responsible for bringing candidate vaccines (viral and bacterial) from lead to clinical phase 1 in an interdisciplinary context, budget responsibility, IP creation & landscape and act as account manager to management team, board of directors and clients. Meaning process development to be able to produce clinical material under GMP including assay development and qualification to generate required CMC sections. Responsible for creating an IMPD and CTD including GGO license's to be able to execute a clinical trial. Development includes product characterization and pre-clinical trials. This requires an interdisciplinary approach including, processes (USP, DSP and formulation), assays, regulatory, pre-clinical, clinical, QC and QA. Includes outsourcing and technology transfers to contract labs and C(D)MO's for analytical services, (pre-)clinical studies, (clinical) materials and F&F. Including leading interdisciplinary teams. Active in RSV (Respiratory syncytial virus), Polio vaccines concepts, Hib (Haemophilus influenzae type b) and an innovative Bioneedle application concept for vaccines.
Participate in the CMC and Product Supply teams to represent Analytical Development and Development QC to bring a product to registration following phase 1 / 2/ 3 including licensing of the product. This in close cooperation with Analytical SME's, Quality, USP /DSP and Drug Product development. Direct report to CMC lead and Director Analytical Development. Functional leading the analytical subteam with up to 10 SME's to support the analytical activities as described. From January 2014 involved in the Ebola program to make a vaccin available for human use. Due to emergency need for a vaccin, an accelerated program of normal 8 years to compressed in 3 years was initiated. This brought changes in working processes and procedures in the organisation. As analytical lead for the program this added a large component of change and stakeholder management to regular program. Responsible in the CMC and Product Supply team for method development, method validation, release testing, stability testing, product specifications, MAA, BLA, IND, CTA, CTD content and review. Including change control and deviation management related to the program. Responisble for outsourcing method development / qualification and product testing. Including transfers, QA agreements and service contract.