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Job Description

Job Title: Manufacturing Associate

Location: Lexington, MA

About the role:

With general supervision you will perform routine and critical manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products.

How you will contribute:

• Troubleshoot and resolve process related issues. Carry out work in a safe manner, notifying management of safety issues and risks. Identify process deviations, troubleshoots issues and identifies process improvements.

• Initiate and document minor deviations and work orders.

• Execution of critical and routine production operations.

• Perform Batch Record, Log Book and Form Prep requests. Enter data in the Laboratory Information Management System (LIMS). Record data into log books, review log book data, and propose document revisions.

• Sample preparation and testing.

• Assembly and disassembly of process equipment, and perform scheduled cleaning and standardization of equipment

• Support change over activities

• Execution of equipment and process qualifications as well as Validation

• Meet and maintain training requirements, complete required training on time.

• Develop and maintain personal development plan. Provide annual performance self assessment on development plan.

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

What you bring to Takeda:

• High school diploma and 2-4 years related industry experience or an Associates Degree in Life Sciences/Engineering field with 1 year of GMP Manufacturing experience.

• Biotech Certificate desirable

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.

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

• The individual is proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures.

• Possess excellent communication and troubleshooting skills.

• Full awareness of current Good Manufacturing Practices.

•  Proficient computer skills.

• Will work holidays and overtime as required.

• May be required to adjust work schedule to meet production demands.

• Proficient in Aseptic Technique

• Ability to work cohesively in a team environment

• Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.

• Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.

• 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).

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 #LI-Onsite

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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