By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role:

As a Senior Manufacturing Associate, you will perform 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. Will support engineering and validation activities.

How you will contribute:

• You will perform cGMP manufacturing operations.

• Standard Operating Procedures (SOP), Batch Records and Form

• Troubleshoot and escalate process related issues Create work orders

• Initiate and document minor deviations

• Execute critical, routine and non-routine production operations

• Inform management of events impacting schedule

• request and execution of GMP documentation

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

• Review manufacturing documentation real time to ensure compliance

• Coordinate sample preparation and testing

• Propose and review document revisions

• Carry out work in a safe manner, notifying management of safety issues and risks

• Participate in tiered visual management system and support continuous improvement initiatives

• Initiating work orders

• Act as subject matter expert for improvement projects

• Perform scheduled cleaning of equipment

• Assembly and disassembly of process equipment

• Perform standardization of equipment

• Support change over activities

• Build equipment and process qualifications and validation

• Provide technical training for area personnel

• Contribute to training material development

• Maintain training requirements and act as a qualified trainer as required

• Develop and maintain personal development plan

• Provide annual performance self-assessment

What you bring to Takeda:

• Normally requires a high school diploma and 4+ years of experience or an associate's degree in Life Sciences/Engineering field with 3 years of GMP Manufacturing experience.

• Biotech certification preferred

• Will 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.

• Proficient in Aseptic Technique

• Work cohesively in a team environment

• Experience with business systems such as, LIMs, MODA and other business systems

• Clear understanding of manufacturing processes and the ability to readily identify deviations in process, controls, and guidelines required.

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.

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

• Proficient in Aseptic Technique

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

• May require weekend or holiday off shift support as needed

• Please be aware that 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.

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

For Location:

USA - MA - Lexington - BIO OPS

U.S. Hourly Wage Range:

$18.85 - $29.62

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

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

No

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.