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Job Description

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.

How you will contribute:

• Responsible for manufacturing technical support including batch records, deviations, change controls, investigations, life cycle management, scale down modelling, satellite runs, process validation, data tracking and trending, and supporting CMC regulatory filings.
• Will perform hands-on laboratory support for the process operations.
• Plays a major role in preparation of technical reports and data summaries.
• Determine day-to-day priorities, with guidance of Supervisor.
• Perform laboratory activities to support Tech Ops projects following established procedures or developing procedures if needed.
• Maintains and operates lab equipment.
• Records and verifies laboratory data.
• Writes and maintains equipment working procedures.
• May assist in training 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 closely with senior level scientists to design and execute the proper studies.
• May serve as a lead author on reports that have limited scope.
• Maintain data integrity and perform data review activities.
• Responsible for maintaining laboratory supplies and reagents.
• May be involved in some direct manufacturing support as required.
• Complies 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.
• Complete mandatory training within required timeframe.

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 highly desirable.
• Must be capable of learning, understanding, and explaining scientific rationale behind upstream unit operations utilized in this role.
• Must have demonstrated 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.
• Organized, team and detail-oriented and able to work in a fast-paced environment.
• Ability to make detailed observations, perform analysis of data and interpret results with minimal guidance.
• Ability to lead projects of limited and well-defined scope.
• Maintains familiarity with relevant scientific literature.
• Self-motivated, developmentally oriented individual.
• Ability to communicate effectively in verbal and written form.

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.
• 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 various meetings, trainings, or external sites; this could include overnight trips.
• Requires approximately 5% travel.

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.

For Location:

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. 

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