Sr Engineer II

Job Description

Senior Development Engineer II
- Upstream

About the role:

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.

How you will contribute:

• 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.

Minimum Requirements /

Qualifications:

• 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.

U.S. Base Salary Range: $ - $

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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.

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

USA - MA - Lexington - BIO OPS

Worker Type:
Employee

Worker Sub-Type:
Regular

Time Type:
Full time

Job Exempt:
Yes