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.
Defines the product technical development strategy in collaboration with TRD functions
Integrates all technology, process, product, and analytical aspects
Integrates commercial requirements, as defined by target product profile
Integrates development (early & late, including Process Evaluation) and manufacturability aspects
Ensures the continuity in process knowledge
Ensures the transfer of expertise to TRD GMP/GIO/MSAT/QC together with the appropriate core team
Addresses the process fine tuning once running in GIO/MSAT/QC
Ensures product and process expertise during the transfer and the commercial manufacturing launch
Coordinates (plan and consolidate results) the manufacturing activities related to clinical, consistency lots and commercial launch
Ensures the latest adoption of science and technology innovation to vaccines programmes
Consolidates CMC data for GRA files and provides product expertise for the file submission and review
Key Responsibilities
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
Accountable for the CMC part of the development of an asset from early stage (candidate commitment/C2C) to file
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
As TDT leader coordinate the execution of all development activities within the frame and organization of the IVP (Integrated Vaccine Plan)
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
Be the technical development representative of the Project Team and contact for GIO strategy partner
Lead the process and analytical transfer to GIO/MSAT/QC up to successful launch
Be the SPOC in the context of outsourcing partnership as appropriate
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
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
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)
Responsible for providing regular progress updates to management
Ensures budget & resource needs per project as appropriate
PhD in Chemistry, Biology, Chemical Engineering, Bioengineering, Biotechnology, Pharmacy or relevant discipline
7+ years’ experience in process and analytical development, scale-up and clinical/commercial development, and manufacturing in the biotechnology or pharmaceutical industry
Experience in leading and direct management of research, process development, and/or manufacturing
Experience in vaccine development processes, knowledge of vaccine manufacturing environment and vaccine industry
Experience with cGMP and FDA regulations and guidelines relating to CMC-related areas
Leadership, managerial and communications skills in a cross-functional environment
Experience in analysis of scientific data and results with ability to review scientific documents including reports, publications and regulatory submissions
Learning agility, high level of autonomy and desire to learn new things outside of one's comfort zone
Critical mindset, pragmatic approach in problem solving
Spoken & written English
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Why GSK?
We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.
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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GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
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