Process Development/ MSAT Scientist

Responsibilities

• Provide MSAT and technical support across process development and manufacturing activities.
• Lead or support manufacturing investigations, change management, and technical assessments.
• Identify opportunities to improve manufacturing processes and support implementation of process improvements.
• Support technology transfer and process implementation from development into manufacturing.
• Cook up technical activities across multiple functions, projects, and stakeholders.
• Establish project milestones, track deliverables, and communicate technical risks and potential solutions.
• Support process validation and process performance activities.
• Contribute to process monitoring, troubleshooting, and ongoing process improvement.
• Support process lifecycle management and maintain strong process knowledge throughout development and manufacturing.
• Prepare and review technical documentation supporting regulatory and manufacturing activities.
• Work with external manufacturing partners to provide technical guidance, resolve issues, and support successful execution of technical activities.
• Apply risk-based approaches to process development and manufacturing challenges.
• Collaborate with scientists, engineers, manufacturing professionals, quality representatives, and other technical stakeholders.
• Support multiple projects and priorities while maintaining strong attention to detail and execution.

Requirements

• PhD in Life Sciences, Chemical Engineering, or a related discipline, or a Master's degree with relevant industry experience, or a Bachelor's degree with significant relevant industry experience.
• Experience in MSAT, Process Development, Technical Operations, Process Engineering, or a closely related function.
• Hands-on experience supporting manufacturing investigations and change management.
• Experience with cell therapy, cell processing, or advanced therapy manufacturing strongly preferred.
• Understanding of cGMP/cGxP requirements within a regulated biopharmaceutical environment.
• Experience with technology transfer and implementation of processes into manufacturing.
• Experience supporting process improvement, process characterization, or lifecycle management activities.
• Familiarity with risk assessment and mitigation methodologies.
• Regulatory submission or technical writing experience is a plus.
• Experience working with external manufacturing partners or CDMOs is a plus.
• Strong project management, organizational, and communication skills.
• Able to independently manage multiple projects and competing priorities.
• Strong interpersonal skills and the ability to work effectively across technical and non-technical teams.