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Job Description

Job Title: Development Associate III

Location: Brooklyn Park, MN

About the role:

As a Development Associate III, you will work with members of the Technical Operations group to lead tech transfers of products into the facility at bench and pilot scale and subsequently to commercial scale. You will provide essential support to the Manufacturing Technical Support team including batch records, deviations, change controls, investigations, life cycle management, scale down modeling, satellite runs, process validation, data tracking and trending, and supporting CMC regulatory filings. You will report to the Sr. Manager, Technical Operations.

How you will contribute:

• Perform hands-on laboratory support, designing experiments for the process operations and/or analytical methods

• Lead projects of limited scope that may involve collaboration

• Provide informal work direction and train development level associates.

• Involvement in the design, execution, interpretation and troubleshooting of analytical test methods, this may include creating experimental plans and determining the next step in an experiment.

• Identify the needs of the lab and recommending purchases or new technologies to supervisor

• Ensure that procedures, lab equipment, data, documentation, and activities within the lab are well-controlled and suitable for their intended use.

• Provide input for and following project tasks and timelines.

• Present and discuss data and experimental conclusions at group and departmental meetings and internal seminars, thus demonstrating confidence, and understanding of the scientific rationale of the experimental designs.

• Author protocols and technical reports to ensure high scientific standards.

• Contribute to deliverables and interfaces with tech transfer teams in the role of process or analytical technical subject matter expert.

• Stay current with industry best practices.

• Provide technical support to Manufacturing or Quality Control.

• Develop an advanced understanding of the drug development process and monoclonal antibody cell culture and downstream purification processes.

What you bring to Takeda:

• Bachelor’s degree in a scientific discipline with 5+ years of relevant experience; or Master’s degree in a scientific discipline with 3+ years of relevant experience 

• Previous experience in a regulated environment would be ideal.

• Demonstrated capability of working in

• Knowledge of the unit operations commonly used in monoclonal antibody manufacturing operations for upstream (cell culture) based positions: aseptic technique, experience propagating mammalian cells, and bioreactor operation.

• Current knowledge of relevant regulatory requirements related to biologic manufacturing and analytical methods to ensure compliance in all activities.

• Demonstrate a high degree of productivity even when doing difficult experiments

• Have considerable experience with instrumentation software administration and computerized systems. 

• Manage and organize complex technical problems.

• Can analyze complex projects which require evaluation of multiple factors and approaches.

• Experience with technical and business writing.

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:

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.

• 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.

• Your work will be a combination of sedentary work and walking /standing for periods of time in Manufacturing Sciences lab environment.

• May require occasional lifting up to 40 lbs.

• Willingness to travel to meetings, trainings, or external sites; this could include overnight trips.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

#GMSGQ  #ZR1  #LI-MA1

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.

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U.S. Base Salary Range:

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.

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Job Exempt