Sr Engineer II

Takeda • Lexington, MA

6d • Hybrid

About The Position

As a key member of the Manufacturing Sciences – Commercial Manufacturing Support Laboratory group, you will be responsible for providing technical and scientific leadership 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 will interact extensively with other departments within Takeda, including Manufacturing, Quality, Process Development, Engineering and Regulatory departments.

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 of working in an upstream or cell culture laboratories
• 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 value creation opportunities for titer or yield increase.
• Design and conduct small scale experiments, analyze and present data to support continuous process improvement activities in manufacturing
• Provide technical expertise in troubleshooting GMP excursions and perform root cause analysis for investigations of complex technical nature
• Evaluate and implement effective and sustainable process control strategy including new Process and Analytical Technologies (PAT)
• Support regulatory inspections, filings and queries as an author and reviewer.
• Provide support to CMC strategy development
• Mentor junior staff as required

Benefits

• U.S. based employees may be eligible for short-term and/ or long-term incentives.
• 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
• Number of Employees: 5,001-10,000 employees