Scientist, Cell Therapy Process Development
Location:
Cambridge , Massachusetts
Posted:
December 17, 2017
Reference:
1702542
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 CMC Scientist in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a CMC Scientist working on the New Modality Development team, you will be empowered to develop processes for cell therapies that will be transformative to patients and work with cross-functional teams to move these therapies into the clinic and beyond, and a typical day will include:

POSITION OBJECTIVES:

  • Provides theoretical/conceptual input to the design, development and execution of research assignments for a specific project or projects within the functional area.
  • Independently plans and executes most unit operation characterization and optimization experiments within expertise and develops an awareness of unit operations in other areas.
  • Responsible for significant or sole technical leadership within project or complex study.
  • Prepares technology transfer documentation and regulatory documents or coordinates with team members to ensure execution.
  • Represents line functions on GCT teams as appropriate/necessary.
  • Proactively identifies process or study issues/challenges and proposes potential resolutions.


POSITION 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/or 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



Qualifications:


LINE FUNCTION SPECIFIC QUALIFICATIONS:

Biologics – New Modalities:

  • Experience in the development and scaling of cell-based therapeutics such as stem cells or CAR-T cells.
  • Hands-on experience in the genetic modification of human primary cells.
  • Familiarity with evolving regulatory expectations for cell therapies, including considerations regarding comparability and product characterization.


EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education and Experience:
Required:

  • Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 8+ years relevant industry experience
  • Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 6+ years relevant industry experience
  • PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 0+ years relevant industry experience
  • Bachelors or Masters: Extensive 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
  • 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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