Mrna Process Development Manager

4 giorni fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

With revenues of more than $35 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

**How will you make an impact?**

You will join a newly established team responsible for cGMP mRNA-based drug production and you will provide oversight and expertise to enable technical success.

As Process Development Manager you will cover a key role in the new organization, focused on leading and building a team of highly qualified scientist. While providing first-hand scientific and technical guidance in Process Development and Technology Transfer projects, you will also act as a point of contact for Clients and all the internal functions (Manufacturing, Quality, Business ).

In this role you will leverage your scientific and technical background as well as your leadership skills in a highly dynamic and international environment, with direct exposure to world-class clients as well as the broader Thermo Fisher Scientific network.

**What will you do?**

Process and Product Development:

- Provides expertise and leadership for the build-up of a team responsible for development and scale-up of mRNA material.
- Develop and implement scalable mRNA purification strategies, including LC-based methods, to generate highly pure material.
- Design, develop, and implement automated workflows for high-throughput mRNA production.
- Proactively identifies development and improvement opportunities, generates a supportive business case, and supports cross-functional teams to deliver those opportunities.
- Uses a data driven approach to progress development deliverables.
- Proactively evaluate new technologies, stay up-to-date with current literature, and implement new features and functionalities into the mRNA platform.
- Responsible for using scientific and GLP/GMP knowledge to support site and global projects.
- Author, review, and approve protocols, SOPs, technical documents, and reports in support of regulatory submissions.
- Interacts with clients and ThermoFisher team to guide development and scale-up of complex processes and communicates risk-based assessments and recommendations to key stake holders. Participate in tech-transfer activities with clients and internal stakeholders ensuring strong relationships with collaborators at different phases of development.

Tech Transfer Project management:

- Maintains continuous contact with clients, focusing 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 monitor project activities to ensure alignment with expectations and agreed-upon timeline.
- Oversee planning, execution and closure of all Feasibility/Development/Scale up phase activities.
- Hold regular meetings and correspondence between internal and client teams.

Operations/Quality Support:

- Serves as interface between PD, MS&T and Operations by representing PD SME in cross-functional forums and informing stakeholder of key information to support the scale-up, tech transfer, and manufacture of pre-clinical and clinical material.
- Utilizes knowledge and experience of GLP/GMP as well as mRNA vaccines to provide technical support for development and manufacture of drug substance and drug product.
- Uses scientific and statistical knowledge to support product, process and testing related investigations and deviations.

**How will you get here?**

**Minimum Requirements**:

- M.S. or PhD in related scientific field with 5+ years relevant industry experience
- Technical expertise in IVTsynthesis, purification methods, analytics (CGE, HPLC, ELISA ), lipid nanoparticle (LNP) formulation required.
- Experience with GLP and GMP compliance and manufacturing preferred.
- Ability to present solutions to complex and strategic issues in a complex matrix environment.
- Experience writing content for technical documentation including SOPs, work instructions, technical protocols and reports, and technical presentations.
- Ability to quickly respond to rapidly changing priorities.
- Flexible and adaptable attitude with the ability to support change management.
- Strong attention to detail.
- Effective verbal & written communication skills in a cross functional environment.
- Experience presenting complex technical concepts to a wide range of audiences of varying technical depth.

At Thermo Fisher Scientific, each one of our 80,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

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