Position Summary:
The role of MSAT Senior Engineer will provide technical leadership for cell therapy manufacturing operations, ensuring processes are robust, scalable, and compliant with GMP standards. The Senior MSAT Engineer will play a critical role in technology transfer, process improvement, facility start-up, and regulatory readiness, supporting both clinical and commercial production.

Essential Duties & Responsibilities:

• Project & Facility Support

• Lead or support projects to improve process robustness, scalability, and GMP compliance.
• Contributes to the construction, qualification, and start-up of new commercial manufacturing facilities.
• Author, review, and approve technical documentation including project plans, test protocols, reports, and SOPs.

• Technical Process Support

• Serve as the MSAT point-of-contact for development, manufacturing, supply chain, QC, QA, and vendor projects.
• Provide hands-on technical support for cell processing operations, including troubleshooting and optimization.
• Lead investigations for process deviations, perform root cause analyses, and implement corrective/preventive actions (CAPAs).

• Data & Compliance

• Analyze process and project data, presenting clear findings and recommendations to stakeholders.
• Ensure compliance with cGMP, safety standards, and company SOPs.
• Support regulatory submissions by preparing technical documentation and data summaries.
• Act as a subject matter expert (SME) during inspections and audits.
• Risk & Material Management
• Identify risks in manufacturing processes and implement mitigation strategies.
• Assess and qualify raw materials, ensuring suitability, reliability, and supply chain continuity.

Qualifications:

• Bachelor’s or master’s degree in chemical engineering, Biochemical engineering, Biotechnology, or related discipline
• 8+ years with a Bachelor’s or 6+ years with a Master’s in MSAT, cell therapy, or biopharmaceutical manufacturing.
• Proven leadership in GMP project implementation, technology transfer, and process troubleshooting.
• Experience with process validation and lifecycle management preferred
• Strong understanding of cell therapy or biopharmaceutical processes, including aseptic processing, cell expansion, and purification.
• Familiarity with GMP, GLP, and regulatory requirements for cell-based therapies.
• Experience supporting regulatory submissions and audits.
• Experience handling human-derived materials in cleanroom environments.
• Familiarity with MES or ERP systems.
• Knowledge of ICH guidelines (Q8, Q9, Q10) and Quality by Design (QbD) principles.
• Excellent problem-solving, analytical, and critical-thinking abilities.
• Strong communication and technical writing skills (SOPs, batch records, reports).
• Ability to work effectively in cross-functional, fast-paced environments.
• Flexibility to occasionally support weekend manufacturing operations.