Mrna Platform Technology Transfer Project Manager

7 mesi fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving analytical challenges, growing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

ThermoFisher mRNA unit in Monza is looking for a Project Manager role

**What will you do?**

**Tech Transfer Project management**:

- Maintains focus on clients’ requirements and the interests of the company.
- Generate key documentation including the, Technology Transfer Master Plan/Scope, Process Gap Analysis between receiving site and transferring site, Technology Transfer Report, Project Timeline and Action Item lists
- Contribute to the strategic definition of new business opportunities while meeting with the existing/potential clients, together with leadership team.
- Lead, track, follow up and supervise project activities to ensure alignment with expectations and agreed-upon timeline.
- Coordinate planning, execution completion of all Feasibility/Development/Scale up phase activities.
- Hold regular meetings and correspondence between internal and client teams.

**Specific duties**:
**New Business Development**:

- Contribute the definition of new business opportunities while meeting with the existing/potential clients, together with Business Management, during technical meetings with the scope of acquiring new products or the revision of the progress status/completion of projects.

**Technology Transfer**:

- Maintain continuous contact with the clients, focusing on the clients’ requirements and the interests of the company.
- Generate key documentation including the Technology Transfer List, Gap Analysis that includes process design, Technology Transfer Plan, Technology Transfer Report, Project Timeline, Action Item lists and project specific protocols/reports.

**Project Management**:

- Lead, track, follow up and supervise project activities to ensure alignment with expectations and agreed-upon timeline.
- Coordinate planning, execution and closure of all Engineering/Feasibility/Optimization phase activities.
- Chair regular meetings and correspondence between internal and client teams.

**Optimization of the Production Costs**:

- Contribute to the optimization of the production process, with continuous efforts to increase project savings on the technical side, while maintaining compliance with cGMP and company procedures.

**Risk Management**:

- Support and advice Business Management with the definition of the technical risks related to the acquisition of the new job orders, through collecting necessary details required for the evaluation, and completing the evaluation, respecting the interests of the company.
- Work closely with the Process Engineer to fully understand scope and requirements for projects triggered by events on existing commercial products.

**PD Relationship Management**:

- If requested, during the project, may also be responsible to coordinate together with the PD manager the development work (with the support of the PD Department)

**Internal Support and Client Relations**:
Provide support and project coordination (where needed) to Validation and Production during the Clinical/Registration/Validation/Stability phase, including review and approval of process clinical/registration/validation documents.

**Internal**:

- All company functions

**External**:

- Potential clients
- Existing clients until the time of the production transfer from the client to Patheon

**GMP & Health & Safety**:

- Ensure cGMP is applied in work area and follows cGMP in all areas of the business.
- Follow all EH & S requirements.
- Observe safety behavior in the working environment.

**Evaluation of the Technical Costs**:

- Support the Commercial Quotes Group with the evaluation of the technical costs of the new job orders, providing the material technical details, production schedule, processes, and supply costs, aligning with the interests of the company

**Job Scope**:

- Thinks within a well-defined frame of reference toward specific objectives in situations characterized by functional practices and precedents.
- Encounters variable situations requiring analytical, interpretive, evaluative and/or constructive thinking.
- Networks with senior internal and external personnel in own area of expertise.
- Erroneous decisions or failure to achieve results normally have a serious effect on the administration of the organization.

**Educatio

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