Manager, Technical Program Design Mrna

1 settimana fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

**TITLE: Manager, Technical Program Design mRNA (Remote)**

**Location: Global (Boston USA area preferred)**

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $40 billion. Each one of our 100,000+ extraordinary minds has an outstanding story to tell. Join us and supply to our unusual mission—enabling our customers to make the world healthier, cleaner and safer

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals

**DISCOVER IMPACTFUL WORK**

**New Business Development**:

- Collaborate with Business Development in advancing new business opportunities to prospective client, director level and C-suite decision makers with respect to mRNA and/or LNP products platforms and equipment/systems, analytics for producing and testing them by providing technical knowledge, and CMC support
- Provide technical solutions and options that assist Clients in achieving their mRNA and/or LNP product development, production requirements, clinical phase of development, regulatory filing strategy and business goals, whilst respecting their budgetary and timeline constraints. Support the promotion of mRNA and/or LNP services technical expertise and services through active participation in Advanced Therapies and biotechnology conferences, trade shows and exhibitions.
- Support new Marketing initiatives and the publication of scientific articles and white papers by providing expert technical advice as the need arises.
- Develops and presents to external groups include trade associations and scientific organizations.
- Responsible for working with operations, process development staff and quality for keeping technical track record and metrics up to date in format to go into site presentations

**Development and Manufacturing Proposals and Scope of Work**:

- Assess client Requests for Proposals (RFP), participate in technical and strategic RFP discussions with the client, and design a technical scope of work for mRNA and/or LNP process development and cGMP manufacturing to support customer strategy.
- Communicate accurate technical and strategic information and new project requirements to the Proposals team to enable accurate proposal generation.
- Review draft and final proposals and Scopes of Work to ensure that the technical scope hours allocated to perform these activities are aligned with Client expectations whilst:

- Achieving a consensus with Operations on the technical scope, work centres, equipment requirements and hours to ensure that project execution and eventual pricing will remain consistent with what is proposed to the client.
- Remain conscious of mRNA and/or LNP services technical constraints and business needs.
- Assist Business Development in reviewing, understanding and presenting proposals to clients.
- Assist with and provide answers to all technical follow-up information requests from clients as needed.
- Accommodate and manage client site visits and prospective project discussions
- Coordinating the transition of the project information with technical contacts & project management team for all awarded projects.
- Travel approximately 25-40%

**KEYS TO SUCCESS**:
**Education**
- At minimum, BS in biological sciences with significant experience in molecular / cell biology with 8+ years industry experience. MS or PhD preferred with 6+ years industry experience.
- 5+ years of experience in scale-up, optimization, and GMP clinical, and commercial mRNA / LNP production
- Prior experience with manufacturing of lipid nano particles (LNP’s) containing mRNA and optimization of formulations.
- Experience in contract manufacturing industry preferred
- Equivalent combinations of education, training, and relevant work experience may be considered.

**Required knowledge, skills and abilities**:

- Subject Matter Expert in techniques used for mRNA and/or LNP production
- Knowledgeable about current regulatory CMC requirements for process development, characterization and validation of RNA processes including how the requirements change with the current different possibly regulatory filing strategies
- A working knowledge of the different analytical assay techniques used for characterization and release of mRNA and/or LNP products.
- Able to scientifically and technically interact with client technical decision-makers and influencers to effectively communicate scientific and business value propositions.
- Understands and is able to effectively communicate cost and timeline implications, advantages, and disadvantages of different manufacturing platforms that can be used
- Effective interact skills with internal business teams and SMEs.
- Stay current with emerging trends in advanced therapies manufacturing.
- Superlative interperson

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