Senior Manager - Technical Development Leader
- PhD or Master in Chemistry, Biology, Bioengineering or Pharmacy.
- Specialized in Biotechnology.
- 10+ years in Upstream or Downstream + a 2nd Technical Development areas among: Primary, Secondary or Analytical Development.
- Proven experience in Late or Early process development.
- Knowledge of Vaccine manufacturing environment.
- Experience with CMC data consolidation or GMP regulations.
- 5+ years in transversal function or team management.
- Leadership of a multidisciplinary team requires broad process development knowledge in order to influence and challenge the different experts reporting in dotted line to the development leader. Need to master process development from early stage to commercial launch.
- Capacity to work in a complex matrix environment and key stakeholders.
- Fluent in English. French and other languages are a plus.
Please see "Basic Qualifications"
Are you interested in joining a dynamic team such as the Technical R&D (TRD) team? Are you interested on having a major impact on the development of future vaccines? If yes, then please read on...
- In line with R&D and Vaccines' Leadership Team strategy, the Technical Development Leader defines, leads and transversally coordinates the technical development from early phase I up to commercial launch.
- You will define the product technical development strategy.
- You will insure the definition of the technical product profile after negotiation with Technical Platform (TP) heads.
- You will integrate all technology and analytical aspects.
- You will integrate commercial constraints.
- You will integrate early & late development (incl. Process Evaluation) and manufacturability aspects.
- You will ensure the continuity in process knowledge.
- You will bring vaccine production expertise within the project.
- You will ensure the transfer of expertise to New Product Introduction (NPI) together with the core team representing all technologies.
- You will address the process fine tuning once running in NPI.
- You will ensure product expertise during the transfer and the commercial manufacturing launch.
- You will perform the Process Validation.
- You will coordinate (plan and consolidate results) the manufacturing activities related to consistency lots and commercial launch.
- You will consolidate technical data for RA files and provide product expertise for the file submission and review.
- Accountable for the establishment of a comprehensive development strategy (incl. the definition of the Technical Product Profile) and plan.
- Negotiate with Technical Platform (TP) heads the resources allocation and development activities to achieve the target.
- Challenge and adjust technical development & strategy on a weekly basis with key members of the Technical Development Team.
- Identify risks on technical feasibility, timing and resources constraints and Seek a remediation plan for identified risks and escalate any technical issues (process and/or analytical ) to the relevant body (project team, TDB,…).
- Consolidate a monthly progress status.
- Coordinate the execution of all development activities within the frame and organization of the IVP (Integrated Vaccine Plan) via a multi-disciplinary Technical Development Team (TDT) composed of all relevant NPD/NPI department functions + R&D preclinical + Analytical R&D/QC + RA representatives.
- 8 to 25 indirect reports (1 to 3 teams Technical Development Teams each consisting of ~8 members).
- Accountable for all the operational development activities of the Primary (from raw material till the purified bulk) and coordinate the operations of the Secondary (from formulation to the packaging operations). If the new project concerns only the Secondary with existing antigens, ensure all those activities.
- Adjust Budget & FTE needs per project.
- Be the technical development representative of the Project Team and contact of the new product manufacturing strategy.
- Lead process and analytical transfer to NPI up to successful launch.
- Accountable for editing & quality of the evidences according to the different stage gates of the IVP.
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.
Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. Part of our R&D programme targets diseases particularly prevalent in the developing world, including the World Health Organisation's three priority diseases - HIV/AIDS, tuberculosis and malaria. Research into candidate vaccines for other diseases of the developing world, such as dengue are at an earlier stage of development.
When it comes to developing the vaccines of the future, we're looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company.
We emphasise the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus.
GSK is one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Vaccines is one of the world's leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world's countries.
For further information, please visit www.gsk.com.
You may apply for this position online by selecting the Apply now button.
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