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

Basic Qualifications:

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

• 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

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• 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

#LI-GSK

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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