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Job Description

About the role:

As a key member of Manufacturing Sciences group, you will be 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 will interacts extensively with other departments within Takeda, including Manufacturing, PTS, QA, QC, PD, Engineering and RA etc.

How you will contribute:

• 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 of 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).

What you bring to Takeda:

• 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 tojuggle 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

• Have excellent knowledge and experience with mammalian cell culture process development, scale-up and scale-down, tech transfer and GMP manufacturing support. 

• Have 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.

• Be customer focused, results oriented, science driven and embrace values.

• Have the attitude to proactively learn new technologies and manage changes in upstream process development and improvement.

• Have experience in GMP working environments
  

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

• Work in a cold, wet environment.

• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

• Occasional travel may be required.

• Occasional weekend support might be required.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

USA - MA - Lexington - BIO OPS

U.S. Base Salary Range:

$86,500.00 - $135,960.00

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. 

EEO Statement

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.

Locations

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.