Posted to MedZilla on 9/22/2017


Takeda Pharmaceuticals

US-MA, Scientist, CMC 1701479-MZ


 
 

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Scientist, CMCin ourCambridge, MA office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Scientist, CMC working on the Analytical Development - Biologics team, you will be empowered to provide support for characterization activities and development of GMP assays for our biologics and cell-based therapy programs. A typical day will include:

OBJECTIVES:

The Analytical Development Biologics group is looking for a highly motivated scientist to provide support for characterization activities and development of GMP assays for our biologics and cell-based therapy programs. The candidate should have a strong cell biology background and be able to apply that knowledge to the development of various cell biology techniques to support programs going into clinical trials. The candidate will provide theoretical/conceptual input to the design, development and execution of research assignments for a specific project or projects within the functional area. They will independently plan and execute most characterization and optimization experiments within expertise and develop an awareness of unit operations in other areas. The candidate will be able to proficiently prepare technology transfer documentation and regulatory documents or coordinates with team members to ensure execution.


ACCOUNTABILITIES:
  • Understands project timelines and deliverables and plans/coordinates project work accordingly with departmental, functional and external stakeholders
  • Provides technical leadership to project teams within area of expertise and commits resources to execute specific project tasks.
  • Contributes significantly and independently to project work which may include multiple projects within functional area.
  • Reviews, interprets and communicates data cross-functionally within CMC and project teams.
  • Plans and implements resolutions to technical problems/issues
  • Represents functional area on GCT project teams by communicating activities from designated functional area to project team
  • Supports local and global initiatives which may include leading initiatives or work streams
  • Serves as a technical resource for junior staff and leverages expertise in laboratory technology as a functional resource/trainer.
  • Independently designs and executes experiments, and reports results
  • Assists with development of project strategy and communicates complex data/decisions within department and cross functionally as necessary
  • Builds and maintains relationships with key vendors and assists with technical aspects of vendor negotiations
  • Proactively analyses manufacturing issues and coordinates potential resolution with the CMC team.
  • Responsible for integrating scientific/technical efforts around cross-functional issues

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education and Experience Required:
  • Bachelors degree in biology, cell biology , biochemistry or related pharmaceutical science and 8+ years relevant industry experience
  • Masters degree in biology, cell biology, biochemistry or related pharmaceutical science; 6+ years relevant industry experience
  • PhD in biology, cell biology, biochemistry or related pharmaceutical science; 0+ years relevant industry experience
  • Bachelors or Masters: Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients, drug products and cell-based therapies under cGMP s
  • Sound knowledge of current Good Manufacturing Practices (cGMP)
  • Previous experience with the use of contract facilities
  • Experience in working in a multi-disciplinary team environment
  • PhD: Demonstrated mastery of subject or area related to field
Knowledge and Skills:
  • Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems, and determine causes and possible solutions
  • Teamwork -- Ability to work well in highly cross functional team environment and across global line functions.
  • Communication Skills -Able to expresses one s self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates issues to supervisor; technical writing skills to support authorship of internal technical documents
  • Organization Exercises good time management and prioritization skills and is able to successfully manage multiple tasks simultaneously
  • Knowledge Sharing - Ability to capture organizational knowledge; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for others to use
  • Resource Management -Ability to manage one s time within individual, departmental, and corporate goals and timelines; management of internal and external resources (vendors)
  • External Involvement Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events
  • Technical - Subject matter expertise and knowledge of applicable lab equipment and operations

TRAVEL REQUIREMENTS:

  • May require approximately 5-10% travel.

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

Learn more at takedajobs.com.

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

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Schedule


Please visit our website at takedajobs.com

 
 


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