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Product Sciences, Product Scientist (Lead)

Boston, Massachusetts

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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Product Sciences, Product Scientist (Lead)

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Job ID R0023009 Date posted 10/06/2020 Location Boston, Massachusetts

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager (Lead), Product Scientist in our Cambridge, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

POSITION OBJECTIVES:

  • Provides technical expertise within the GMSci Drug Product organizations responsible for product knowledge for Takeda's small molecules, biologics and plasma derived therapy portfolio
  • Serves as the subject matter expert (SME) across multiple products
  • Provides leadership for regulatory interactions including CMC content for dossiers
  • Ensures product knowledge is shared and leveraged across sites and functions

POSITION ACCOUNTABILITIES:

  • Provides strong understanding of product quality, impurities, stability, and characterization as well as structure-function relationships
  • Responsible for providing rationale for the justification of specifications considering history of the method and the manufacturing process
  • Reviews and approves non GMP reference standard and reference material qualification protocols and reports
  • Accountable for non GMP analytical methods
    Accountable for one or more products in the portfolio
  • Accountable for continuity of these aspects across time and sites
  • Responsible for CMC sections in dossiers related to these aspects
  • Provides strong leadership and alignment for initiatives and investigations related to these aspects which are complex
  • Works with Small Molecules Drug Product Process Sciences to conduct Design of Experiment (DoE) studies and implement Quality by Design (QbD) to improve robustness of analytical methods. Analyze statistical data and its impact on manufacturing process

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Education / Experience

  • Degree in engineering or life sciences
  • BS with a minimum of 10 years experience, MS with a minimum of 8 years experience with deep expertise in analytical methods for biologics characterization and commercial release
  • Experience operating globally in a matrixed organization highly preferred

Highly desired skill

  • Experience working with pharmaceutical stability studies, analytics and quality control.

Skills

  • Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.
  • Communicates effectively and frequently with supervisor, line function and peers.
  • Successfully and succinctly conveys complex information in both written and oral forms.

Behaviors

  • Focusing on the few priorities and provide superior results
  • Elevating capabilities for now and the future
  • Being able to work cohesively with different teams
  • Eagerness to learn and grow

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement Company match of charitable contributions
  • 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

Empowering Our People to Shine

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0023009

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