The companyOur client is a professional Pharmaceutical and Biotechnology organisation, based in Zuid-Holland Netherlands. They develop vaccines that are the first or best in their class and protect against some of the world's most life-threatening infectious diseases. The pathogens against which vaccines are developed include Ebola, Respiratory Syncytial Virus (RSV), Human Immunodeficiency Virus (HIV), Extra-intestinal Pathogenic E. coli (ExPEC), Methicillin-Resistant Staphylococcus Aureus (MRSA), polio and influenza.
Role descriptionYou represent the functional area (Analytical Development) on the CMC team, acting as a single point of contact for the CMC Team Leader and Line Manager. You lead a functional sub-team containing other functional reps and Subject Matter Experts and you are responsible for the planning and executing of functional project deliverables in close collaboration with the line to the desired cost and quality level.
You ensure technical representation of the line organization in CMC project teams, coordinate project deliverables in close collaboration with the CMC Team Lead and functional line management. Furthermore, you maximize the generation and use of knowledge to not only support project objectives but also to grow departmental functional expertise (re-useable knowhow).
For this position you must be available on-site at least 3 days per week, with flexibility to switch days.
Responsibilities• Represents the functional area (Analytical Development) on the CMC team, acting as a single point of contact for the CMC Team Leader and Line Manager.
• Leads a functional sub-team containing other functional reps and Subject Matter Experts and is responsible for the planning and executing of functional project deliverables in close collaboration with the line to the desired cost and quality level.
• Responsible for project related functional area deliverables during all CMC stage gate phases
• Responsible for functional budget alignment (CMC project to line resource owner)
• Develops the project functional strategy (Analytical Development) in consultation with the line ensuring to the fullest possible extent the leverage of expertise gained in other projects (re useable knowledge), Develops the plan in alignment with CMC team/TPP.
• Ensures alignment and endorsement of CMC strategy within the functional line organization. Highlights gaps and or deficiencies in departmental functional strategies and or infrastructure (using expertise of SME and or functional reps) and engages line management to address these gaps when conflicting/hindering project objectives.
• Drives partnership and collaboration between the functions and ensures that the customer (internal & external) requirements are well understood by their teams and are used as main drivers for development.
• Responsible for successful functional process technology transfer to the plant/CMO including process-fit-to-plant activities.
• Responsible for maintaining oversight and control over activities at CMO.
• Responsible for the co-ordination of all sub-team activities required to support the governance model (e.g. STR), including the active tracking and monitoring of stage gate deliverables and the integration of the stage gate deliverables into the functional project team.
• Responsible for the generation of appropriate risk management scenarios in close consultation with the sub team, functional SME and line organization to mitigate project incurred delays arising from factors like technology and/or operational execution risks.
• Responsible for the continuous optimization and streamlining of the project development timelines in close collaboration with the project sub team, SME and line.
• Responsible for ensuring that adequate technical content review of regulatory submission (module 3) has taken place by the appropriate SME. Co-ordinates and collates any activities relating to the review process within the functional sub teams and ensures consistency in content
• Responsible for coordination of spec setting process for functional area on behalf of CMC lead.
Requirements- A masters or PhD in Chemistry, Pharmacy, or equivalent life sciences;
- A minimum of 8 years pharmaceutical industry experience preferably in a biopharmaceutical drug development environment
- Experience in in Analytical Development
- The ability to lead multidisciplinary teams of professionals and foster team productivity in a matrix environment
Other informationSubmit your application before the 15th of November.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.