Sr Engineer I - Upstream

Role Summary

Sr Engineer I - Upstream at Takeda. Responsible for providing technical and scientific tools to support upstream processes for commercial production and late stage clinical production of Biologics, including process and product investigations/troubleshooting, continuous process improvement and life-cycle management, technology transfer and process validation. You will lead or contribute as a key member of various cross-functional teams and interact extensively with other departments within Takeda.

Responsibilities

• Participate in the execution of continuous process improvements, aimed at improving robustness, capacity, and productivity.
• Implementation of effective and sustainable process control strategy including new Process and Analytical Technologies (PAT).
• Mentor junior staff.
• Execute continuous process improvements, aimed at improving robustness, capacity, and productivity. Provide technical expertise and leadership in identifying opportunities/areas, planning, designing and conducting experiments, analyzing data and documenting results towards continuous upstream process improvement, including reducing recurring deviations, and increasing level of safety and/or compliance.
• Provide technical expertise and leadership in trouble-shooting and root cause analysis for process discrepancies and quality investigations of complex technical nature.
• Support CMC, regulatory inspections and filings as an author and reviewer.
• Provide high quality written study proposals, research and development reports, and investigation reports.
• Support Validation methodologies on the floor. Implement effective and sustainable process control strategy including new Process and Analytical Technologies (PAT).

Qualifications

• BS in Chemical Engineering or related disciplines with a minimum of 5 years of experience or MS in Chemical Engineering or related disciplines with a minimum of 3 years of experience.
• A PhD in Chemical Engineering or related disciplines with 0 to 4 years of relevant experience in a biotechnology/pharmaceutical environment.
• Proven record of technical capabilities.
• Proven ability to work in a fast-paced environment with demonstrated capacity to juggle multiple tasks and demands.
• Hands-on experience in process characterization leading to definition of design space (preferred).
• Experience in development and implementation of process control strategy using QbD principles (preferred).
• Experience in implementation of disposables in manufacturing of biologics.
• Experience with application of risk-based approach in decision making related to process improvement and troubleshooting of manufacturing unit operations (preferred).
• Excellent knowledge and experience with mammalian cell culture process development, scale-up and scale-down, tech transfer and GMP manufacturing support.
• Experience in design-of-experiment (DoE) and the ability to analyze and interpret data collected.
• Demonstrate teamwork/collaboration and the ability to communicate appropriately and effectively.
• Customer focused, results oriented, science driven and embrace values.
• Attitude to proactively learn new technologies and manage changes in upstream process development and improvement.
• Experience in GMP working environments.

Skills

• Technical leadership in upstream bioprocessing
• Process characterization and DoE
• QbD and PAT applications
• Root cause analysis and investigations
• Cross-functional collaboration

Education

• BS/MS/PhD in Chemical Engineering or related disciplines as specified in qualifications

Additional Requirements

• Occasional travel may be required.
• Occasional weekend support might be required.
• Work in controlled manufacturing environments with required protective equipment.