Job PurposeThe 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 headsAccountable 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 partnerLead 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 discipline7+ years' experience in process and analytical development, scale-up and clinical/commercial development, and manufacturing in the biotechnology or pharmaceutical industryExperience in leading and direct management of research, process development, and/or manufacturingExperience in vaccine development processes, knowledge of vaccine manufacturing environment and vaccine industryExperience with cGMP and FDA regulations and guidelines relating to CMC-related areasLeadership, managerial and communications skills in a cross-functional environmentExperience in analysis of scientific data and results with ability to review scientific documents including reports, publications and regulatory submissionsLearning 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.?Find out more:?Please visit to learn more about the comprehensive benefits program GSK offers US employees. Why Us?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.Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
