Manufacturing Science and Technology Senior Scientist

Role Summary

The MSAT Senior Scientist provides a critical technical role for the Commercial Manufacturing & Supply Chain, focused on Cell and Gene therapies. Under supervision, the Senior Scientist is responsible for product commercialization activities (PPQ, PLI readiness etc.), post-approval process monitoring (CPV, OOS, OOT and Deviation handling), change management and support of process related investigations.

Responsibilities

• Develops timelines, communicates with key stakeholders, to ensure MSAT activities are prioritized and executed to meet the requirements of the program. Contributes to cross-functional teams (VCGT, External Manufacturing, Supply Chain, and Quality functions) to ensure that process validation, technology transfer, deviation management, process monitoring and post-approval change management are managed within agreed processes and are on target.
• Resolves issues independently, where possible, and escalates other risks appropriately.
• Partner effectively and manage relationships with external CDMOs and key suppliers to meet manufacturing and program goals.
• Through the development of process data driven reports, support compliance and efficiency related projects working towards the goal of continuous improvement to increase value and efficiency.
• Provide support and applicable manufacturing process related content for CMC regulatory submissions and assist with technical CMC regulatory/Agency questions.
• Actively participates in daily operations related meetings to support manufacturing operations
• Actively participates in supporting Vertex agenda items through the Joint project teams with our CDMO business partners.
• Provides trainings and technical presentations as required.

Qualifications

• Bachelor's Degree in science or related discipline is required and equivalent experience.
• Significant Experience with process development and technical support of commercial biological products and cGMP manufacturing. Experience with Cell and Gene therapies preferred.
• Knowledge of US and EU cGMP regulations/guidance.
• Experience with technology transfer, process validation and process monitoring.
• Direct experience working with contract manufacturing organizations (CDMO) and/or technical service partners.
• Technical experience supporting manufacturing quality compliance including deviations, change controls and CAPAs

Skills

• Strong background in Cell and Gene Therapy pharmaceutical manufacturing processes and technologies.
• Knowledge of current Good Manufacturing Practices (cGMP) and regulatory requirements related to pharmaceutical manufacturing.
• Experience with process development and scale-up of pharmaceutical manufacturing processes, including process optimization, troubleshooting, and validation.
• Experience with statistical analysis (including JMP) for process optimization and validation.
• Excellent communication skills, both verbal and written, with the ability to communicate complex technical information to a range of stakeholders.
• Strong problem-solving and critical thinking skills, with the ability to analyze data and make sound technical recommendations.
• Strong leadership skills to contribute to, and provide technical guidance to, cross-functional teams.
• Travel required: 25% primarily in the EU and some (limited) US travel.