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Particle Lab Specialist

Employer
Takeda
Location
Lexington, Massachusetts
Start date
Nov 10, 2023

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Job Details

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: Particle Lab Specialist (QC Analyst)

Location: Lexington, MA

About the role:

As the Particle Lab Specialist, you will perform characterization testing on visible particles identified during GMP operations from released raw materials through finished drug product and product complaint sample. You will implement new technologies and documentation, and drive Maintenance and Qualification support of the equipment. You will be the Subject Matter Expert (SME) for particle testing including support of investigations and documentation of results. You will report to the Head Network Center of Excellence Particle Testing Analytical Services and Support.

How you will contribute:
  • Review and Approve of Test Protocols, Test Procedures and Test Documentation in Quality Management Systems.
  • Be responsible for documentation, review and approval of Test Performance and Results according to internal Guidances and cGMP Guidelines.
  • Use equipment Logbooks and performing documentation in Logbooks and other systems, as well as SOP's and associated forms.
  • Be responsible for Laboratory Equipment and areas as assigned (including Coupa orders, vendor correspondence, inventory and quote requests).
  • Actively participate in Continuous Improvement Projects, Improvement of Processes and Improvement of Documentation (including EHS and 5S projects/tasks/requirements).
What you bring to Takeda:
  • Bachelor's degree in Science, preferably in Chemistry, Biology, or related technical degree
  • 2+ years of experience in Pharmaceutical Manufacturing and GxP or QC related experience is required.
  • Technical knowledge of analytical technologies, Equipment, documentation, compliance and Lab practices.
  • Practical knowledge of Quality Management Systems
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 environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
  • No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
  • Will work in a cold and/or wet environment.
  • Must be able to work multiple shifts, including weekends.
  • Non-Exempt Roles only: Must be able to work overtime as required.
  • May be required to work in a confined area.
  • Some Clean Room and cool/hot storage conditions.

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

#LI-MA1

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

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Company

Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.

For more information, visit https://www.takeda.com.

Stock Symbol: TAK

Company info
Website
Location
650 East Kendall Street
Cambridge
MA
02421
United States

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