01 ago - Monza
Thermo Fisher Scientific
**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.) **Job Summary**:
The mRNA Engineering Project Manager (Band 5) provides strategic and operational leadership for complex, cross-functional engineering projects supporting the development, scale-up, and commercialization of mRNA-based products. The role is accountable for end-to-end project execution, stakeholder alignment, and delivery of engineering outcomes in compliance with quality, regulatory, and business requirements. **Key Responsibilities**: - Lead complex, multi-disciplinary engineering projects related to mRNA process development, scale-up, tech transfer, and GMP manufacturing readiness.
- Provide project leadership across Engineering, Process Development, Manufacturing, Quality, Validation, Supply Chain, Automation, and external partners.
- Define and own project strategy, scope, timelines, budgets, resources, risks, and mitigation plans.
- Drive decision-making, proactively manage dependencies, and resolve cross-functional issues impacting project delivery.
- Oversee engineering activities related to equipment, facilities, automation, and process optimization.
- Lead technology transfer activities from development to GMP manufacturing sites.
- Ensure full compliance with GMP, EHS,
and applicable regulatory requirements throughout the project lifecycle.
- Prepare and deliver project governance updates, executive-level summaries, and risk assessments.
- Mentor junior project managers or technical team members, as applicable.
- Contribute to continuous improvement initiatives in project management processes and engineering execution. **Required Qualifications**: - Bachelor’s or Master’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related field.
- Extensive experience managing complex engineering projects in pharmaceutical, biotech, or advanced therapies environments.
- Strong understanding of mRNA technologies, biologics manufacturing, or similar complex drug product processes.
- Proven experience working in GMP-regulated environments.
- Demonstrated ability to lead cross-functional teams with a high degree of autonomy and accountability.
- Excellent stakeholder management, communication, and decision-making skills. **Preferred Qualifications**: - Direct experience supporting mRNA or nucleic acid-based products.
- Experience with tech transfer to GMP manufacturing sites.
- Project Management certification (PMP, Prince2, or equivalent).
- Experience operating in fast-paced, highly regulated, and matrixed organizations. **Competencies**: - Strategic project leadership
- High-level problem-solving and risk management
- Ability to influence without direct authority
- Strong execution focus and accountability
- Clear, concise communication at all organizational levels **Work Environment**: - Matrix organization with senior stakeholder interaction
- Responsibility for high-impact, high-visibility projects
- Potential multi-site or external partner engagement
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