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Job Description

Job Title: Manufacturing Associate

Location: Lexington, MA

About the role:

As a Manufacturing Associate, you will perform routine and critical manufacturing operations to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. You will operate production equipment according to SOPs for the production of clinical and/or commercial products. You will report to the Supervisor, Manufacturing.

How you will contribute:

• Carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps.

• Troubleshoot and resolve basic process related issues, recognize and escalate deviations, and execution of critical and routine activities in support of production

• Perform Batch Record, Log Book and Form Prep requests

• Enter data in the Laboratory Information Management System (LIMS) , MODA and or other business functions

• Review GMP documentation and identify changes for documentation

• Sample preparation and testing

• Participate in tiered visual management system and support CI initiatives

• Manage equipment and support facility related projects by Initiating work orders, assembly and disassembly of process equipment, scheduled cleaning of equipment, standardization of equipment, supporting change over activities and execution of equipment and process qualifications as well as validation.

• Maintain training requirements

• Perform daily operations of the work unit and actively assists coworkers in fulfilling department goals elevating issues to senior staff.

• May require interaction with equipment, technical and supply item vendors.

• May be required to perform as a subject matter expert for equipment and/or systems

What you bring to Takeda:

• Normally requires a high school diploma and 0-4 years related industry experience or an Associate’s Degree in Life Sciences/Engineering field.

• Biotech Certificate preferred

• Proficient in Aseptic Technique

• Proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures.

• Possess troubleshooting skills.

• Full awareness of current Good Manufacturing Practices.

• Proficient computer skills.

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:

• This position is considered “Essential Personnel.”  This means that in the case of inclement weather (e.g. snow storm) the employee who occupies this position may be expected to report to work for their normal shift if management deems necessary.   To ensure “Essential Personnel” are safe during inclement weather situations Shire may provide lodging, shuttle service, and food (depending on the severity and duration of the inclement weather event).  These details will be provided by management prior to any potential inclement weather situation.     

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses/goggles, 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 around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

• Ability to lift, pull or push equipment requiring up to 25-50 lbs. of force.

• Ability to stand for 6 hours in a production suite.

• Ability to climb ladders and work platforms.

• Stooping or bending to check or trouble-shoot equipment operations.

• Ability to work around chemicals (alcohols, acids & bases)

• May require weekend or holiday off shift support as needed

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

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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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