Senior Engineer Upstream, MSAT

Bora Biologics•San Diego, CA

106d

About The Position

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

Requirements

Bachelor’s or higher degree in chemical/biochemical engineering, chemistry/biochemistry, biological sciences, or related fields.
BS degree with a minimum of 10 years of relevant experience, including at least 3 years of direct MSAT experience; or MS degree with at least 8 years of relevant experience and 3 years of direct MSAT experience; or PhD with a minimum of 3 years of relevant experience in biopharmaceutical research and manufacturing, including 3 years of direct MSAT experience.
Understanding statistical methods and their use in upstream technology transfer and product lifecycle management.
Ability to inspire innovation, foster collaboration, ensure transparency, and enhance team effectiveness.
Strong interpersonal, verbal, and written communication skills, coupled with digital literacy.
Proficiency in MS Word, Excel, and PowerPoint.
Comprehensive knowledge of cGMP regulations, guidance, and quality systems.
Advanced expertise in biopharmaceutical manufacturing processes and equipment.
Ability to work efficiently and independently in a dynamic and changing environment.

Nice To Haves

Familiarity with statistical software such as JMP is desirable.

Responsibilities

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.
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.