Senior Specialist - Clinical Trial Material Project Lead - 6 months fixed term contract

Job description

Nombre del sítio: Belgium-Wavre
Fecha de publicación: Feb 23 2024

Job purpose:

GMP Manufacturing and Clinical Supply (GMP Mfg.) is critical to robust product and process development and launch of novel vaccines. The CTM project Lead function is instrumental in supporting this work from Development into TRD and from TRD out to GIO for commercial scale manufacturing.  These individuals will serve at the GMP experts, following the products and processes through the development manufacturing lifecycle, ensuring quality of product and process and, ultimately, reproducibility, scalability and manufacturability.  Each of these individuals is accountable for an efficient, timely and cost effective CTM manufacturing, in alignment with TDL project plans; and for being the GMP Mfg. point of contact for the whole organization.  The CTM project Lead will serve as the technical platform expert in TRD GMP, ensuring new capabilities developed in Research are implementable into GMP environment in GIO. You will ensure GMP is ready to receive these capabilities.  You will provide guidance and recommendations on new technologies for development and improvements to existing, as needed. CTM project lead ensures the CTM timely availability regardless where the material is produced.

Your responsibilities:

·  Represent CTM manufacturing and GMP aspects into TDT and represent TDT into TRD GMP M&CS. Function as the link between GMP Mfg. and the TDT; participate in appropriate core meetings across all stages to assure the appropriateness of the manufacturing process and to adapt, as needed, to meet GMP expectations and remain efficient and flexible. The global nature of the role may require minimal travel. Have E2E view on multiple vaccine projects from starting material to DP release. Contribute to project road map with GMP manufacturing constraints and ensure CTM manufacturing planning is fitting with project needs. Drive execution, coordinate and track progression of GMP Mfg plans against agreed milestones in collaboration with TDLs/tPMs and CTM planning function.
·  Identify and consolidate risks associated to CMT manufacturing in a phase-appropriate environment, including but not limited to: feasibility of manufacturability, timing and resources constraints, limited product and process knowledge, new incoming materials. Develop remediation plans and/or phase appropriate controls to reduce or accept risk.
·  Support the TDL at governance meetings to ensure readiness and appropriateness of stage gate evidence in the process development value stream (PDVS) concept.
·  Contribute to vaccine projects PIP set-up (tPM lead) with GMP manufacturing needs (equipment and resources) when CTM production occurs in GIO.
·  Lead the transfer of new vaccine products and technologies from Development into GIO for PPQ production. Support PPQ strategy, review and approve PPQ protocol and report. Contribute to and drive platform strategy and technical transfer planning into GIO, with final accountability for the execution of these technical transfer through managing the groups executing this work, autonomously and aligned with business priorities, Quality by Design principles, and the GMP Quality Framework. Initiate Strategy eCC for PPQ manufacturing.
·  Lead the transfer of new vaccine products and technologies from Development into GIO for CTM production. Initiate and coordinate the CTM manufacturing eCC when produced in GIO. Review and approve Production Method generated by development when CTM production is performed in GIO. Request master data creation when CTM production is performed in GIO. Ensure Manufacturing readiness when CTM production is performed in GIO. Manage product impacting deviation. Review and approve PSF, write GMP manufacturing file source document when CTM production is performed in GIO. Consolidate and review CTM manufacturing file source document. Ensure timely closure of all GMP documentation to ensure batch release when CTM production is performed in GIO.
·  Own and maintain product and process knowledge throughout the entire development life cycle, bridging Research and Commercial Operations.
·  Embed QbD, QF, PDVS, and GMPs in the GMP Mfg network, ensuring Quality is respected while speed and agility are retained by aligning product development strategies with these key initiatives.
·  Act as the GMP Mfg voice at key technical and business governance meetings.
·  Act as SPOC representative for Technical Transfer QMS (GQP, VSOP, ...). Own the CTM technical transfer SOP (transfer to GIO and CMO).

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

·  University degree in Biology, Biochemistry, Chemical Engineering, Bioengineering, Pharmacy, or other relevant discipline.
·  A good understanding of biopharma / vaccine processes and GMP manufacturing knowledge across all product stages (PhI/II/III and commercial). 
·  Communication across all organizational levels is required.  Ability to communicate issues, risks, data, and make decisions.  Equally important is the ability to lead within a large matrix international organization, build successful collaborations within and outside GMP Mfg.
·  Total education and experience in biopharma-related domain of at least 8 years.
·  Good level of written and spoken French and English.

Si tiene una discapacidad y necesita asistencia durante el curso del proceso de selección, tendrá la oportunidad de hacernos saber qué asistencia específica necesita para hacer los arreglos adecuados.

Nuestro objetivo es ser una de las empresas de atención médica más innovadoras, de mejor desempeño y más confiables del mundo. Creemos que todos aportamos algo único a GSK y cuando combinamos nuestros conocimientos, experiencias y estilos, el impacto es increíble. Únase a nuestra aventura en GSK donde se inspirará para hacer el mejor trabajo para nuestros pacientes y clientes. Un lugar donde puede ser usted mismo, sentirse bien y seguir creciendo.

    

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