Senior Engineer II

Takeda • Lexington, MA

36d • Hybrid

About The Position

As a key member of the Manufacturing Sciences – Downstream Laboratory group, the Senior Engineer II will be responsible for providing technical and scientific leadership to support Downstream 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 will interact extensively with other departments within Takeda, including Manufacturing, QA, QC, PD, Engineering and RA etc. You will report to the Head of Downstream Manufacturing Sciences.

Requirements

• A PhD in Chemical Engineering or related disciplines with a minimum of 4 years of relevant experience in a biotechnology/pharmaceutical environment; or MS in Chemical Engineering or related disciplines with a minimum of 6 years of experience; or BS in Chemical Engineering or related disciplines with a minimum of 8 years of experience is required
• Experience working in a laboratory
• Proven record of technical capabilities
• Proven ability to work in a fast-paced environment with demonstrated capacity to juggle multiple tasks and demands

Responsibilities

• Lead and 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 Downstream 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 investigations of complex technical nature
• Support regulatory inspections and filings as an author and reviewer.
• Provide support to CMC strategy development
• Provide high quality written study proposals, research and development reports, and investigation reports
• Evaluate and implement effective and sustainable process control strategy by utilization of Process and Analytical Technologies (PAT)

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree