6 days old

Cell Therapy Data & Information Systems Manager

Millennium Pharmaceuticals, Inc.
Boston, MA 02109
  • Job Code
    R0036621

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Job Description

Are you looking for a patient-focused, innovative-driven company that will inspire you and support your career development? If so, be empowered to take charge of your future at Takeda. Join us as a Data & Information Systems Manager in CMC Data Management of Cell Therapies at our Cambridge 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 a wavering 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 in Cell Therapies.

You will have the opportunity to apply your knowledge and partner with industry-leading professionals in oncology, drug discovery, translational research, process engineering and development, cGMP Manufacturing, analytical development, formulations, and quality assurance as you engage in cutting-edge therapeutic programs. The successful candidate will have extensive experience supporting the compliant integration of systems, processes, workflows, and integrated cross-functional data informing Cell Therapies strategies in CMC.

POSITION OBJECTIVES:

The Cell Therapy Pharmaceutical Sciences CMC team is pursuing several programs in clinical studies, development and cGMP Manufacturing, in addition to managing Takedas commercial cell therapy assets and product life cycle management. This positions primary role is to provide hands-on support and maintain best-in-class electronic data management systems encompassing the broad range of data streams associated with Cell Therapies development and manufacture. In this role you will contribute to Takedas Cell Therapy autologous and allogeneic platform strategies, working cross-functionally with discovery, process and analytical development, translational sciences, pharmacology, data sciences, CMC and modeling teams.

POSITION ACCOUNTABILITIES:

  • Support best-in-class end-to-end electronic data management for Cell Therapies Translational Engine in CMC development, manufacturing, and translational sciences towards clinical trials regulatory filings.

  • Employ systems to integrate quality data from across Takeda CMC pipelines and processes to derive insights and inform key program decisions.

  • Provide data summaries, dashboard, relevant data and trends early to support CMC strategies and program milestones.

  • Perform routine analyses of data to monitor transfer, quality, integrity, and compliance to data governance best practices and guidelines.

  • Execute product-centric KPI dashboards to illustrate on-going manufacturing performance based on key metrics.

  • Develop end user applications that support visualization.

  • Ensure appropriate compliance for the capture of the various categories of data generated (21 CFR Part 11).

  • Deploy computationally efficient cloud-based technologies to maximize systems efficiency.

  • Support data inquiries; provisions of data for CMC analytical and process development, manufacturing, clinical

  • Troubleshoot problems, address issues, and answer questions from internal users, collaborators, and customers

  • Build strong partnerships with Manufacturing, Engineering, Analytics, Translational, and Quality to ensure seamless execution of daily production schedules.

  • Actively communicate and work cross-functionally to ensure a collaborative work environment with colleagues in Research, Analytical and Process Development, Automation and Engineering, Quality and Manufacturing, and Data Integration teams at domestic and international sites.

EDUCATION, EXPERIENCE, AND SKILLS:

  • PhD, or MS with 3 years, or BS with 5+ years of relevant experience in Information Systems, Data Analytics, Engineering, Computer Science, or a related field

  • Strong analytical and problem-solving skills

  • Strong knowledge in pharma and familiarity in a highly-regulated environment (e.g., GLP- and GMP-compliant); Cell or Gene Therapy manufacturing experienced preferred.

  • Technical Cell Therapies knowledge and/or biotech process knowledge, process parameters and analytics to support investigations is a plus.

  • Ability to work with electronic system for data compilation including LIMS, MES, SAP, etc.

  • Knowledge of high-level computing languages: R, C/C++, Python, Java, Perl, and willingness to learn other(s)

  • Strong knowledge in software and language (e.g., R, SAS, MATLAB)

  • Experience with distributed computing, database (e.g., SQL) or relational databases (e.g., PostgreSQL), and Amazon Web Services. Database programming and dashboard experience preferred.

  • Experience with any of the following: Agile software development, Seven Bridges, Arvados, Git, React

  • Experience in data integration, programming, and evaluation of analytical tools

  • Self-motivated and detail-oriented, with excellent interpersonal and time management skills

  • Excellent written and verbal communication, organizational skills, and a strong team player

  • Ability to drive initiatives, decisive decision-maker with proven ability to deliver excellence, and excel in a matrix environment

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.

#LI-KD1

This job posting excludes CO applicants.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2021-06-07 Expires: 2021-07-06
Sponsored by:
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Cell Therapy Data & Information Systems Manager

Millennium Pharmaceuticals, Inc.
Boston, MA 02109

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