Technical Development Leader
Stiefel Laboratories, Inc
Toscana, Italy
27 gg fa

Your Responsibilities : Job Purpose

Job Purpose

  • In line with the R&D and VLT strategy, the Technical Development Leader defines leads and transversally coordinates the technical development from early phase I up to commercial launch.
  • Define the product technical development strategy
  • Ensure the definition of the technical product profile after negotiation with TRD function Heads
  • Integrate all technology and analytical aspects
  • Integrate commercial constraints
  • Integrate early & late development (incl. Quality by Design) and manufacturability aspects
  • Ensure the continuity in process knowledge
  • Bring vaccine production expertise within the project
  • Ensure the transfer of expertise to GMP units together with the core team representing all technologies
  • Address the process fine tuning once running in GMP units
  • Ensure product expertise during technical transfer and the commercial manufacturing launch
  • Perform the Process Validation
  • Consolidate technical data for RA files and provide product expertise for the file submission and review
  • Key Responsibilities

  • Accountable for the establishment of a comprehensive development strategy (incl. the definition of the Technical Product Profile) and plan
  • Negotiate with TRD Function 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.
  • Escalate any technical issues (process and / or analytical ) to the relevant body (project team, TRDB, )

  • Provide input to a monthly progress status
  • Drive 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 TRD department functions + R&D preclinical + QC + RA representatives

  • Accountable for all the operational development activities of the Drug Substance (from raw material to purified bulk) and coordinate the operations of the Drug Product (from formulation to the packaging operations).
  • Adjust Budget & FTE needs per project
  • Be the technical development representative of the Project Team (VDT, VCT) and contact of the GIO manufacturing strategy
  • Lead process and analytical transfer to GIO up to successful launch
  • Accountable for the redaction & quality of the evidences according to the different stage gates of the IVP (commit to Research, FTIH, ) for VRDB and VIB
  • Basic qualifications :

  • Master in chemistry, biology, bioengineering or pharmacy
  • 10+ years in upstream or downstream + a 2nd technical development area among : primary, secondary or analytical development.
  • Proven experience in Late or Early process development and process transfer.
  • Knowledge of Vaccine manufacturing environment
  • Experience with CMC data consolidation or GMP regulations
  • 5+ years in transversal function or team management
  • Spoken & written English
  • Preferred qualifications :

  • PhD in chemistry, biology, bioengineering or pharmacy
  • Skills : Strategic thinking, Communication, Presentation skills, Synthesis capacity, Negotiation, Facilitating, Influencing, Project management, Flexibility, Mobility
  • Why GSK? : Our Offer :

    Our Offer :

    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.

    The Department :

    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.

    Our Company :

    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.

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