Senior Engineer Upstream, MSAT

Job Description

Job Description

Description :

The Senior Engineer in Upstream 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 upstream manufacturing processes and technologies. The ideal candidate is self-motivated, detail-oriented, productive in collaborative environments, and proficient in both oral and written communication across various functional areas and technical

Essential Duties

• Utilize advanced engineering principles to facilitate the transfer, monitoring, validation, and troubleshooting of upstream 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.
• Upstream Process Optimization : Lead optimization efforts for cell culture, fermentation, and other upstream process parameters to maximize yield and product quality.
• Raw Material Management : Oversee qualification, sourcing, and supply of raw materials critical to upstream 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 process design parameters, address process excursions, and resolve technical challenges collaboratively.
• Continuous Improvement : Apply Lean, Six Sigma, or other continuous improvement methodologies to upstream operations, driving process efficiency and robustness.

Supplemental Responsibilities.

Requirements : Education

Knowledge, Skills, and Abilities