SUMMARY 

The Senior Engineer in Downstream Manufacturing Science and Technology (MSAT) serves as the Subject Matter Expert (SME) for the company’s current and emerging product portfolio. This role is pivotal in leading and advancing MSAT functions, supporting cGMP manufacturing. The responsibilities include overseeing technology transfer, monitoring, troubleshooting, and enhancement of downstream manufacturing processes and technologies

JOB RESPONSIBILITIES

Essential 

· Utilize advanced engineering principles to facilitate the transfer, monitoring, validation, and troubleshooting of downstream manufacturing processes.

· Collaborate with cross-functional teams, including Process Development, Quality, Supply Chain Management, Manufacturing, and Engineering, at decision-making levels.

· Drive the adoption and implementation of new technologies aimed at improving manufacturing efficiency and streamlining operations.

· Plan and execute long-term technology initiatives, including proposing, designing, and implementing advanced scientific experiments that contribute to program objectives and expand knowledge within the field.

· Develop and support the MSAT team by motivating employees, providing coaching and feedback for individual career development, recognizing contributions, resolving conflicts, facilitating team activities, providing training, and promoting best practices.

· Downstream Process Optimization: Lead optimization efforts for cell culture, fermentation, and other downstream process parameters to maximize yield and product quality.

· Raw Material Management: Oversee qualification, sourcing, and supply of raw materials critical to downstream manufacturing processes.

· Facility Fit: Assess the feasibility of new manufacturing processes, materials, and technologies and document as a facility fit reports.

· Tech Transfer Documentation: Prepare comprehensive documentation to support technology transfer between sending sites or scales, ensuring knowledge continuity and regulatory compliance.

· Client Interactions: Lead and facilitate client meetings and technical discussions to define downstream process design parameters, address process excursions, and resolve technical challenges collaboratively.

· Continuous Improvement: Apply Lean, Six Sigma, or other continuous improvement methodologies to downstream operations, driving process efficiency and robustness.

Supplemental Responsibilities.

· Support the design and implement scale-down models with PD team to support troubleshooting, process characterization, and technology transfer activities.

· Lead the collection and statistical analysis of manufacturing in-process control and process parameter data to monitor process performance and prepare campaign summary reports as required.

· Guide investigations into process-related deviations, evaluate their impact on product quality, identify root causes, and recommend corrective and preventative actions.

· Introduce and implement new equipment and process technologies in manufacturing areas, train personnel on these technologies, and act as a technical resource for equipment capabilities and troubleshooting.

· Recommend and initiate improvements in process and equipment operation based on solid engineering and scientific principles to enhance process robustness, efficiency, and productivity.

· Author standard operating procedures (SOPs) and batch records for new processes and technologies as needed.

· Contribute to regulatory filings and inspections.

· Collaborate with internal and external development and manufacturing teams to support process scale-up, technology transfer, process characterization, and validation.

· Provide technical and process support on the manufacturing floor.

· Deliver training and guidance on process and technical operations to manufacturing staff, and, if necessary, recommend and present disciplinary actions to subordinates.

Manufacturing Support as PIP during manufacturing campaigns