Sr. Director Process Development and MSAT - Viral Vectors and mRNA

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Business Job Title: Senior Director, BioProcess Sciences

Group/ Division: PSG (Pharma Services Group)/ Drug Substance

Career Band: 10

Position Location:  Seneffe, Belgium ( Site - Based)

Number of Direct Reports: 4-8

Company information
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $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 complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them. Our team of more than 100,000 colleagues 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. For more information, please visit www.thermofisher.com
 

How will you make an impact?
Reporting to the Vice President of Development and Scientific Solutions for Drug Substance, The Senior Director, Process Development will provide end-to-end scientific, technical, and organizational leadership across Process Development (PD) and Manufacturing Sciences & Technology (MSAT) for the Viral Vector and mRNA Businesses. This role is accountable for the full process lifecycle—from early-stage development through technology transfer, validation, and commercial manufacturing support—ensuring robust, scalable, and compliant processes.

This leader will integrate development and manufacturing science capabilities to accelerate delivery, enhance process robustness, and strengthen client outcomes. They will serve as a key strategic partner to internal stakeholders and external clients, ensuring seamless transition from development to GMP manufacturing while maintaining operational excellence and regulatory compliance.

What will you do?

Strategic & Organizational Leadership

• Provide strategic direction and operational leadership across Process Development (analytical, upstream, downstream) and MSAT functions.
• Build and scale a high-performing, integrated organization aligned to business growth and client demand.
• Lead organizational design, workforce planning, succession planning, and talent development across PD and MSAT.
• Establish clear performance metrics, KPIs, and accountability frameworks to ensure delivery excellence.
• Drive a culture of innovation, continuous improvement, and scientific excellence.

Process Development Leadership

• Lead analytical, upstream, and downstream process development activities to support viral vector and mRNA programs from early development through late-stage readiness.
• Ensure development of robust, scalable, and transferable processes aligned with manufacturing requirements.
• Oversee technical strategy for process characterization, optimization, and control strategies.
• Ensure alignment between development and manufacturing to minimize tech transfer risk.

MSAT & Manufacturing Support

• Lead all MSAT activities including technology transfer, process validation, continued process verification, and GMP manufacturing support.
• Oversee facility fit assessments and ensure successful process scale-up and implementation.
• Direct process start-up activities including engineering runs, clinical manufacturing, PPQ, and commercial production.
• Provide scientific leadership for deviation investigations, process monitoring, and ongoing process improvements.
• Ensure lifecycle management of manufacturing processes in alignment with client strategies.

Technology Transfer & Lifecycle Management

• Own end-to-end technology transfer from Process Development into manufacturing, ensuring efficiency and robustness.
• Implement best-in-class transfer methodologies and risk mitigation strategies.
• Ensure seamless integration between development, MSAT, manufacturing, and quality functions.

Client & Stakeholder Engagement

• Serve as executive sponsor and primary scientific interface for key client programs.
• Lead interactions with clients, including Joint Steering Committees and governance forums.
• Partner cross-functionally with Manufacturing, Quality, Supply Chain, and Facilities to ensure program success.

Quality & Regulatory Compliance

• Ensure all activities comply with cGMP, regulatory requirements (FDA, EMA), and internal quality systems.
• Support regulatory filings, inspections, and responses to health authorities.
• Ensure proper change control, documentation, and validation practices are maintained.

Operational & Financial Leadership

• Own and manage departmental budgets, resource allocation, and financial performance.
• Drive operational efficiency and productivity improvements across PD and MSAT.
• Balance portfolio demands to ensure on-time, high-quality delivery.

Experience & Skills

• Ph.D. in Biochemistry, Chemical Engineering, Molecular Biology, or a related scientific discipline; Master’s degree with extensive relevant experience will also be considered.
• 15+ years of progressive leadership experience in biologics process development, with a strong track record in CDMO or biopharmaceutical environments.
• Significant leadership experience in biologics process development and/or MSAT within a CDMO or biopharmaceutical environment.
• Demonstrated success leading large, multidisciplinary teams across analytical, upstream, downstream, and manufacturing science functions.
• Deep expertise in biologics process development, scale-up, technology transfer, and commercial manufacturing support.
• Strong knowledge of cGMP, regulatory expectations, and process validation lifecycle.
• Proven ability to integrate development and manufacturing functions to improve speed, quality, and scalability.
• Experience in client-facing roles with strong executive presence and communication skills.
• Financial and operational acumen, including budgeting, resource planning, and organizational scaling.
• Strong problem-solving, decision-making, and change leadership capabilities.
• Experience working in global, matrixed, and cross-functional environments.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.