Job Purpose
The Technical Development Leader is accountable to lead the development and delivery of the CMC technical strategy to deliver novel vaccine candidates from early phase I up to commercial launch. The role holder will have a unique opportunity to shape delivery of the future vaccine candidates to positively impact the health of up to 2.5 billion people by the end 2030.
1. Defines the product technical development strategy in collaboration with TRD functions
2. Integrates all technology, process, product, and analytical aspects
3. Integrates commercial requirements, as defined by target product profile
4. Integrates development (early & late, including Process Evaluation) and manufacturability aspects
5. Ensures the continuity in process knowledge
6. Ensures the transfer of expertise to TRD GMP/GIO/MSAT/QC together with the appropriate core team
7. Addresses the process fine tuning once running in GIO/MSAT/QC
8. Ensures product and process expertise during the transfer and the commercial manufacturing launch
9. Coordinates (plan and consolidate results) the manufacturing activities related to clinical, consistency lots and commercial launch
10. Ensures the latest adoption of science and technology innovation to vaccines programmes
11. Consolidates CMC data for GRA files and provides product expertise for the file submission and review
Key Responsibilities
12. Accountable for the establishment of a comprehensive technical development strategy (incl. the definition of the technical product profile) and of acceleration options in alignment with Vaccine Development Team and Strategy heads
13. Accountable for the CMC part of the development of an asset from early stage (candidate commitment/C2C) to file
14. As cross-functional Technical Development Team (TDT) leader, composed of all relevant Technical R&D functions + R&D preclinical + ARD/QC + Regulatory + Quality + Global Industrial Operations (GIO) representatives, develop, challenge and adjust technical development & strategy on a regular basis with key members of the TDT
15. As TDT leader coordinate the execution of all development activities within the frame and organization of the IVP (Integrated Vaccine Plan)
16. Identify risks on technical feasibility, timing and resources constraints and seek a remediation/mitigation plan for identified risks and escalate any technical issues (process and/or analytical) to the relevant internal forum
17. Be the technical development representative of the Project Team and contact for GIO strategy partner
18. Lead the process and analytical transfer to GIO/MSAT/QC up to successful launch
19. Be the SPOC in the context of outsourcing partnership as appropriate
20. Accountable for ensuring the principles of quality by design (QbD) and quality risk management are applied in the development of a robust, fit for purpose, process
21. Accountable for the redaction & quality of the technical evidences, according to PDVS process and the different stage gates of the IVP for internal governing bodies
22. Accountable for all the operational development activities of the primary (Drug Substance (DS) including raw material) and coordinate the operations of the secondary (Drug Product (DP) including packaging operations)
23. Responsible for providing regular progress updates to management
24. Ensures budget & resource needs per project as appropriate
25. PhD in Chemistry, Biology, Chemical Engineering, Bioengineering, Biotechnology, Pharmacy or relevant discipline
26. 7+ years’ experience in process and analytical development, scale-up and clinical/commercial development, and manufacturing in the biotechnology or pharmaceutical industry
27. Experience in leading and direct management of research, process development, and/or manufacturing
28. Experience in vaccine development processes, knowledge of vaccine manufacturing environment and vaccine industry
29. Experience with cGMP and FDA regulations and guidelines relating to CMC-related areas
30. Leadership, managerial and communications skills in a cross-functional environment
31. Experience in analysis of scientific data and results with ability to review scientific documents including reports, publications and regulatory submissions
32. Learning agility, high level of autonomy and desire to learn new things outside of one's comfort zone
33. Critical mindset, pragmatic approach in problem solving
34. Spoken & written English
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In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.
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