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Scientific Informatics Product Manager, GxP & Novel Modalities (Biology and Chemistry Capabilities and Products Team)

Boston, Massachusetts

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Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

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We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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

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Scientific Informatics Product Manager, GxP & Novel Modalities (Biology and Chemistry Capabilities and Products Team)

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Job ID R0022116 Date posted 09/10/2020 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 Scientific Informatics Product Manager, GxP & Novel Modalities (Biology and Chemistry Capabilities and Product Team).

As part of Scientific Informatics, the Biology and Chemistry Capabilities and Products team has a mission to develop strategy and design & implement systems, tools and products using the latest technologies to accelerate Takeda's drug discovery and pharmaceutical sciences development and achieve a higher quality of Life for patients. Delivering Cell and Gene Therapies to patients is a new strategic direction for Takeda, where, unlike other more traditional therapies, in cell therapies, discovery, process development, clinical development and manufacturing activities are tightly coupled and the patient is the immediate focus of all stages of development. To meet accelerated goals of delivering cell therapies to patients, Takeda is in the process of establishing the infrastructure, technologies and resources to support this new and transformative domain including the development of a Clinical phase I/II manufacturing facility for cell therapies.

As an IT Product Manager, you will manage delivery and oversight of GxP compliant technologies to support Cell Therapies and other transformative domains. In this role, working closely with the Scientific Lab Computing group and manufacturing teams to develop product roadmaps and act as IT lead and system/product manager for IT technology efforts at GMP facility.  You will have the opportunity to work closely with others in Scientific Informatics and will collaborate closely with Scientists, QA, and engineers to deliver and maintain quality technology products and platforms supporting our GMP work in novel therapies. In this role, you will contribute to Takeda’s mission to achieve a higher quality of life for patients.

OBJECTIVES:

  • Manage delivery, strategy and oversight of health authority compliant (cGMP and other GxP) informatics software solutions used in Takeda’s pharmaceutical sciences division in support of novel therapies including cell therapies and gene therapies. The primary site is Takeda’s state-of-the-art cGMP facility in Cambridge where cutting-edge Cell Therapy research is performed. Gene Therapies research is conducted in Austria and Boston with some additional GMP manufacturing conducted in Japan.
  • Manage the key relationships between the R&D stakeholders and Scientific Informatics to deliver on business opportunities and outcomes and, to drive continuous delivery of value using agile IT life cycle management from product prototyping, development, optimizations and renewals to product terminations.
  • Lead the development of one or multiple product strategies for GxP technologies used for scientific data, fitting into long-term roadmaps and drive the product priority-setting of capabilities and features in response to business needs aligned with IT architecture, deployment and product and release management.
  • Proactively monitor and maintain product related end-to-end customer/business experiences and influence relevant stakeholders to support and deliver successful product releases.
  • Partners with peers within R&D and IT to drive continuous improvement of data management, service processes, user experiences and application optimization aligned with business stakeholders.

ACCOUNTABILITIES:

  • Engage and align with scientific R&D stakeholders, QA, and IT on current business plans, strategies and future opportunities and developments, providing product recommendations to build a pipeline of meaningful releases.
  • Manage and influence key stakeholders across business and technology, to develop and convey product visions.
  • Ensure and drive the development of a product vision, strategy and roadmap whilst aligning key stakeholders-based capability and features needs.
  • Maintain- and serve as the communicator- of the product vision.
  • Use broad knowledge of GxP quality requirements, IT, lab informatics software solutions, new and established technology developments and consult with key players to enhance products, to define products, to develop prototypes and to develop a roadmap for ongoing and new product developments.
  • Lead and guide the development of products by using persuasion and negotiating skills to reach agreement on approach, development and implementation.
  • Lead and manage the Product Life Cycle(s) for the business, by translating potential pipeline products to agile development project, work closely with development teams to create new business product releases focusing on additional and/or new functionality, product simplification and to increase transparency.
  • Drive the product planning fitting in long-term roadmaps and aligned with short-term release plans.
  • Drive prioritization of the product backlog to keep agile teams unblocked and aligned.
  • Participate and lead gathering of research to identify articulated and non-articulated product needs.
  • Closely monitor product portfolios and business composition, gather relevant data to continuously gain new insight and adjust roadmaps, offering to optimize performance and effectiveness.
  • Manage and take responsibility for sustainability of the end-to-end customer experience of products developed.
  • Estimate approximate workload requirements and timeline predictions for several to many professionals and continuously monitor and prioritize product developments and workflow and capacity to deliver the most significant value to the product users.
  • Communicate issues and successes up and down in the project groups, IT and the business.
  • Oversee and manage product budgets established in consultation with stakeholders by balancing resources, vision development, prototyping and sustain product teams to deliver and maintain the product.
  • Continually monitor and refine the product and lead and influence the performing service management and expert opportunities to optimize use experiences.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Required:

  • Bachelor’s degree or equivalent in a scientific discipline, computer science or business administration is preferred.
  • 6 years or more of relevant professional experience in pharmaceutical research or development or related area.
  • Substantial experience in at least one of GMP manufacturing, Cell Therapies R&D or Gene Therapy R&D
  • Professional in-depth knowledge of product and project management in pharmaceutical industry.
  • Experience in stakeholder relationship management. Influential in orchestrating key stakeholders and product teams to turn product vision into reality.
  • Excellent oral and written communication skills, business acumen, and enterprise knowledge.
  • Extensive experience in design or in implementing solutions or products with integrated quality and efficiency improvements.
  • Work with virtual/agile teams in different locations, aligning and adapting different work, culture and communication styles.
  • Familiarity with regulated systems and an understanding of computer systems validation

Preferred:

  • Master’s degree or higher
  • Familiarity working in a lean, agile and waterfall software delivery team is preferred.
  • Is an accomplished practitioner of design thinking, with a proven track record of developing and exploiting deep customer insights.
  • Experience with the design and development of pharmaceutical life science products.
  • Able to think outside the box and is able to convince stakeholders.
  • Experience in GMP manufacturing for cell therapies and deploying lab informatics solutions and/or clinical supply solutions
  • Understand of design thinking and ability to explain and convince stakeholders.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0022116

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