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Manufacturing Associate - Nights

Company: Takeda
Location: Lexington
Posted on: February 12, 2024

Job Description:

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 Notice and 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

Job Title: Manufacturing Associate - Nights
Location: Lexington, MA

About the role:

As the Manufacturing Associate, you will perform routine and critical manufacturing operations, including work functions in Cell Culture, Purification, Solution & Equipment Prep areas. You will operate production equipment according to standard operating procedures (SOP's) for producing clinical and/or commercial products. You will report to the Supervisor, Manufacturing.

How you will contribute:

  • Carry out cGMP manufacturing operations using Standard Operating Procedures (SOP), Batch Records and Form Preps.
  • Troubleshoot and resolve basic process related issues including recognizing and escalating deviations
  • Execution of critical and routine activities to support production.
  • Perform Batch Record, Logbook and Form Prep requests.
  • Enter data in the Laboratory Information Management System (LIMS) , or MODA other business systems
  • Review GMP documentation.
  • Sample preparation and testing.
  • Identify changes needed to documentation.
  • Participate in tiered visual management system and support CI initiatives
  • Manage equipment and support facility related projects including initiating work orders, assembly and disassembly of process equipment, perform scheduled cleaning and standardization of equipment.
  • Support change over activities and execution of equipment and process qualifications and validation.
  • May perform as a subject matter expert for equipment or systems.
  • Identify process deviations, troubleshoots issues and identify process improvements.
  • May require interaction with equipment, technical and supply item vendors.

    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 would be ideal.
    • Proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures.
    • Prior troubleshooting skills and full awareness of current Good Manufacturing Practices.
    • Proficient computer skills.
    • May require weekend or holiday off shift support and flexibility to adjust work schedule to meet production demands.
    • Proficient in Aseptic Technique.

      What Takeda can offer you:

      • Comprehensive Healthcare: Medical, Dental, and Vision
      • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
      • Health & Wellness programs including onsite flu shots and health screenings
      • Generous time off for vacation and the option to purchase additional vacation days
      • Community Outreach Programs and company match of charitable contributions
      • Family Planning Support
      • Professional training and development opportunities
      • Tuition reimbursement

        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.
        • Climb ladders and work platforms
        • Lift, pull or push equipment requiring up to 25-50 lbs. of force.
        • Stoop or bend to check or troubleshoot equipment operations.
        • Please be aware that this position is considered "Essential Personnel." This means that in the case of inclement weather (e.g. snow storm) you will 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 before 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.

          This posting excludes Colorado applicants.

          #GMSGQ #ZR1

          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.


          USA - MA - Lexington - BIO OPS

          Worker Type


          Worker Sub-Type


          Time Type

          Full time

Keywords: Takeda, Boston , Manufacturing Associate - Nights, Other , Lexington, Massachusetts

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