Training Project Specialist
Il y a 2 mois
**Company Information**
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
**Position Overview**
The training Project Specialist will be responsible for training projects, strategic initiatives and continuous improvement within a state-of-the-art multi-product cell therapy manufacturing facility that will be utilized to manufacture autologous and allogeneic cell therapy products.
This individual will partner with the different functions within the organization to support personalized cell therapy production through safe and compliant operations according to cGMP requirements
**Major Responsibilities**
- Execute training related projects through Lean Six Sigma, DMAIC, 5S, and additional relevant project management tools. Present and report project deliverables to peers, relevant stakeholders and Senior Management.
- Lead strategic training related projects (e.g. Legend Academy) and optimization projects
- Be the SPOC of the training department into the different overall project milestones sub teams
- Execute projects (in collaboration with the other training team functions) according to project timelines, resource availability, capability of the training team, and serve as point of contact to company's PMO organization, in supporting the company/corporate programs from the training team perspective.
- Support the creation, monitoring, scheduling, and implementation of projects related to the Training business requirement. Align with all involved stakeholders to meet the GXP requirements.
- Lead the functional QI (Quality Investigations) activities and ensure on time closure of deviations, Quality investigations and CAPA's related to operational activities. Ensure good CAPA effectiveness checks on day-to-day activities.
- Take accountability for best practices as per Legend Biotech policies and GXP requirements. Ensure compliance of operational activities with GXP, quality, training, EHS, security
- Establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels within the organization
- Establish excellent relationships with internal and external stakeholders. Ability to interact with all levels within the organization, and especially other training departments/employees, EH&S, PMO/OPEX, Supply Chain, MS&T, Quality, Maintenance & Engineering & Manufacturing.
**Qualification**
**Education**:
Master degree in life sciences or related field or equivalent experience required
**Experience**:
- A minimum of six (6) years of experience in cGMP/FDA regulated industry is needed
**Capabilities, Knowledge, and skills**:
- Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
- Strength in communicating and working effectively with broad stakeholders in various scientific/technical/business disciplines.
- Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
- Very strong influencing capabilities with an ability to interact and communicate effectively at all levels of the organization and across different functions.
- Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels within the organization.
**Language(s)**:
Fluent in English, preferably fluent in Dutch
Legend Biotech maintains a drug-free workplace.
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