Development Associate II

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Job Description

Job Title Development Associate II

Location Brooklyn Park, MN

About The Role

As a Development Associate II, you will work with other 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 manufacturing technical support 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 Senior Manager of Technical Operations.

How you will contribute

• Determine daily priorities, with guidance of Supervisor.
• Perform hands-on laboratory support for the process operations and/or analytical methods.
• Prepare technical reports and data summaries.
• Perform laboratory activities to support Tech Ops projects following established procedures or developing procedures.
• Maintain and operate lab equipment.
• Record and verify laboratory data.
• Write and maintain equipment working procedures.
• May help train other Development Associates.
• Draft studies and investigations of moderate scope and work on problems in which the analysis of the situation or data requires a review of identifiable factors.
• Work with senior level scientists to design and implement the proper studies.
• May serve as a lead author on reports that have limited scope.
• Maintain data integrity and perform data review activities.
• Maintain laboratory supplies and reagents.
• May be involved in some direct manufacturing support.
• Comply with the safety guidelines while performing laboratory work.
• Develop a basic understanding of the drug development process.
• Develop an understanding of monoclonal antibody cell culture and downstream purification processes.
  
  

What you bring to Takeda

• Bachelor’s degree in a scientific discipline with 2 years of relevant experience; or Master’s degree in a scientific discipline with 0-3 years of relevant experience.
• Previous experience in a regulated environment would be ideal.
• Understand, and explain scientific rationale behind downstream unit operations.
• Must have demonstrated knowledge of methodologies for analytical-based positions; HPLC, ELISA, RT-PCR, SDS-PAGE, UPLC, spectroscopy, IEF.
• Knowledge of the unit operations commonly used in monoclonal antibody manufacturing operations for upstream (cell culture) or downstream (purification) based positions aseptic technique, experience propagating mammalian cells, bioreactor operation, column chromatography, ultrafiltration/diafiltration processes.
• Comfortable in operating laboratory equipment and associated software independently and training of junior level associates.
• Make detailed observations, perform analysis of data and interpret results.
• Lead projects of limited and well-defined scope.
• Maintain familiarity with relevant scientific literature.
  
  

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.
• In general, the position requires 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 several meetings, trainings, or external sites; this could include overnight trips.
• Requires approximately 5% travel.
• 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.
  
  

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.

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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

Brooklyn Park, MN

U.S. Base Salary Range

$67,900.00 - $106,700.00

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

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes