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Job Description

About the role:

Therole is responsible for executing all processes in productionwhile strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. In addition to making routinerevisionstodocuments,he/she may rewrit e c omplex procedures or initiate new procedures as applicable. The incumbent has enough applied technical knowledgetoperform complex trouble shooting tasks and may even assist during the transfer of new technologies into manufacturing. He/She has sufficient technical and administrative competence to organize and lead production activities, including demonstrating leadership in state-of-the-artcGMPcompliance,andenvironmental health andsafetyskills.

How you will contribute:

• Prepare media and buffer solutions.

• Operate Clean-in-Place (CIP)and Steam-in-Place systems.

• Assemble andoperatefiltration systems.

• Operategeneral production equipment(such as pH andconductivitymeters,autoclave, portable mixers, etc.)

• Monitor andrecord critical processparameters.

• Complete all relevant paperwork following GDP/GMP guidelines.

• Perform routine maintenance and cleaning of productionequipmenttomaintain in GMP fashion.

• Perform sampling using aseptictechniques.

• Participate on ContinuousImprovement Teams.

• Trainand mentor other team members.

• Write, reviseandreviewpertinent documentation as appropriate.

• Troubleshoot process problemsandrespondtoprocess alarms.

• Assist with process/equipmentvalidationand data analysis.

• Work with other groups such as maintenance/metrologytoensurepreventative maintenance is done.

• Initiate and/or coordinate other process improvement projects.

• May perform other duties as assigned.

• Knowledge of cGMP manufacturing.

• Knowledge of basic laboratoryandpharmaceuticalproductionequipmentincludingbut not limited to: autoclaves,process tanks, incubators,analyticalequipmentandCIP/SIP systems.

• Must be able toapplyquantitative analysis toanalyzeprocess performance.

• Incumbent must be proficient in a variety of mathematical disciplinesand be able towork with both the metric and USA standards of measurement.

• Must be able toreadandfollow detailed written instructions andhavegoodverbal/written communication skills. Goodproceduralwriting skills.

• Knowledge of basic chemical andbiological safety procedures.

• Good computer skills, knowledge of Microsoft Word andExcel.

• Very goodinterpersonal skills and be able toworkeffectivelyand efficiently in a team environment.

• Must haveand display the followingpersonal attributes: Integrity,trust,workethic, sound judgment, intellectual honesty, and conviction.

Inventory Technician:

• Responsible to execute materialtransfers that includenon-hazardous,hazardousand flammable chemicals tosupportmanufacturingscheduleadherence.

• Maintain a visualreplenishmentprogram of materials using lean manufacturing processes/tools.

• Maintain records of materials in inventoryand on order.

• Compile inventory records as needed.

• Reconcile discrepancies in inventories.

• Compile information on receipt andtransfer of materials.

• Resolve questions andproblemsandrefers only most complex issues tohigherlevels.

• Contribute to a culture of safety first in compliance with Environmental,Health,and Safety (EHS).UnderstandandfollowJobHazardAnalysis(JHA)packets.

• Must have experience with inventory management.

• Experience in handlingpallet-jacks,pallettrucks,andforkliftsare a plus.

What you bring to Takeda:

• Typically requires a high school diploma or GED plus 2+ years of experience or associates’ degree or higher and 1+ years related work experience.

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:

• Must be able to carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment).

• Must be able to stand for extended periods of time over an entire 8 or 12-hour shift.

• Must be able to climb ladders and stairs while wearing special gowning.

• May require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks.

• May be required to work in a confined area.

• Some Clean Room and cool/hot storage conditions.

• May require immunization before performing work within the manufacturing area.

• 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.

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

• May work in a cold, hot or wet environment.

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

• Willhandlenon-hazardous,hazardousandflammablematerials/chemicals.

• May require immunization beforeperformingwork within the manufacturingarea.

• Must be able to work multiple shifts, including weekends. Must be able to work overtime as required.

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

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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