Senior Manager, Cryopreservation Process Engineer

About the role

The Senior Cryopreservation Process Engineer plays a pivotal role in the development, scale-up, technology transfer, facility design, startup, qualification, and operational readiness of cell processing and cryopreservation manufacturing operations. This role requires a blend of GMP knowledge, facility design, aseptic processing techniques, and process knowledge to support the development of technologies for cell and gene therapy products.

Responsibilities

• Provide operational expertise based on a combination of GMP knowledge, facility design, aseptic processing techniques, and process knowledge in the development of technologies for cell and gene therapy products.
• Support development and implementation of GMP support processes, including cleaning, environmental monitoring, gowning, waste management, GMP documentation, and related operational requirements.
• Translate user requirements into operationally efficient processes and support user acceptance testing to ensure systems and processes meet performance, quality, and business requirements.
• Support development and implementation of change control, risk assessment, qualification, and validation strategies to ensure operational readiness and scalability within applicable quality and regulatory requirements.
• Develop and implement robust operational documentation, including standard operating procedures, work instructions, electronic batch records, training materials, and other manufacturing documentation.
• Develop and maintain an end-to-end understanding of material, document, waste, and sample flows; identify risks related to process, contamination, cross-contamination, and mix-ups; and drive improvements in collaboration with Operations, QA, QC, and other functions.
• Act as a technical lead for root-cause investigations and resolution of safety, quality, process, and operational issues within the assigned area.
• Serve as a subject matter expert for the assigned area during health authority and regulatory inspections and support inspection readiness activities.
• Lead or support the design, implementation, and continuous improvement of manufacturing information technology systems, including SAP, MES, automation, and other digital solutions.
• Develop appropriate governance and performance-monitoring structures to assess operational performance during acceptance testing, facility startup, and ongoing commercial operations.
• Develop and maintain a strong understanding of manufacturing processes, including sound scientific principles, operational procedures, and the manufacturing environment covering facilities, utilities, equipment, systems, and processes.
• Develop and maintain strong technical knowledge of aseptic processing and cell processing techniques, as well as applicable regulatory frameworks including cGMP and ATMP requirements and biosafety expectations.
• Support future expansion and site-readiness initiatives, including area readiness, equipment readiness, and operational readiness activities required to enable successful commercial manufacturing batch production.
• Lead and/or support projects related to process improvements, departmental priorities, manufacturing performance, capacity, technology, equipment, quality, and other business needs.
• Provide technical and operational support to the team as needed, including troubleshooting, issue resolution, cross-functional coordination, project execution, and day-to-day manufacturing readiness activities.

Qualifications

• Minimum of a Bachelor's degree or equivalent experience in Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry, or a related scientific or engineering discipline.
• Minimum of 4 years of relevant professional experience.
• Experience in one or more of the following areas: cGMP manufacturing, operations technology development, technology transfer, process and equipment validation, or quality management.
• Demonstrated ability to collaborate effectively across functions and within a matrix organization.
• Strong startup mindset with the ability to proactively identify issues, develop solutions, and drive execution.
• Ability to operate effectively in a rapidly changing environment while maintaining flexibility, accountability, and strict adherence to procedures and guidelines.
• Ability to work independently, prioritize and manage multiple activities simultaneously, and integrate cross-functional issues into effective solutions.
• Strong technical, analytical, problem-solving, communication, and project-management skills.

Preferred Experience

• Experience in a plant or commercial manufacturing environment.
• Experience with equipment and systems commissioning, qualification, and validation (CQV).
• Experience deploying new technology into manufacturing operations, including IT/automation systems.
• Cell and gene therapy (CAR-T) manufacturing or cryopreservation experience.
• Experience with continuous improvement, Lean/Six Sigma, process engineering, and operational excellence.

Additional Responsibilities / Capabilities

• Agile decision-making and effective issue escalation.
• Coaching, collaboration, and cross-functional leadership.
• CORRECTIVE AND PREVENTIVE ACTION (CAPA), critical thinking, and structured problem solving.
• Process engineering, product/process improvements, product costing, and supply chain management.