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Sr. Scientist/Scientist, CMC Analytical

Company: Takeda Pharmaceutical
Location: Framingham
Posted on: August 6, 2022

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 About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as a Senior Scientist/Scientist, CMC Analytical where you will provide theoretical/conceptual input to the design, development and execution of research assignments for projects within the functional area. You will also coordinate cross-functional teams and resolutions, with a focus on scientific/technical challenges. Provide theoretical/conceptual input to the design, development and execution of research assignments for a specific project or projects within the functional area. Develop projects or technical strategy within area of expertise. Leverage analytical technical skill(s) as a resource/expert within Analytical Development, and responsible for sole technical leadership within project or complex study. As part of Analytical Development, you will report to the Director. How you will contribute:

  • Development, and responsible for sole technical leadership within project or complex study.
  • Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and reports within expertise for review.
  • Coordinate transfer of projects.
  • Identify and plan broader technical objectives (project and scientific related) with input from manager.
  • Coordinate others in creating technical reports including reviewing and editing.
  • Provide training/mentoring for junior staff.
  • Identify and recommend vendors. Minimum Requirements/Qualifications:
    • Bachelors degree in chemistry, biology, pharmacy, or related pharmaceutical science and 11+ years (Sr. Scientist) or 8+ years (Scientist) relevant industry experience
    • Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 9+ years (Sr. Scientist) or 6+ years (Scientist) relevant industry experience
    • PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 3+ years (Sr. Scientist) relevant industry experience
    • Strong knowledge of analytical techniques with advanced experience in multiple techniques such as LC, GC, MS, dissolution
    • Experience representing Analytical Development in a cross functional CMC environment
    • Multiple experiences with methods development, validation and transfer
    • Experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP's
    • Sound knowledge of current Good Manufacturing Practices (cGMP)
    • Previous experience with the use of contract facilities
    • Previous experience contributing to regulatory filings
    • May require approximately 5-10% travel. 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
      • Flexible Work Paths
      • Tuition reimbursement 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 position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
        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 Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time

Keywords: Takeda Pharmaceutical, Framingham , Sr. Scientist/Scientist, CMC Analytical, Other , Framingham, Massachusetts

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