Associate Scientific Fellow - CMC
Location:
Cambridge , Massachusetts
Posted:
November 22, 2017
Reference:
1702851
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 an Associate Scientific Fellow in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Scientific Fellow working on the New Modality Development team, you will be empowered to develop processes for microbiome therapeutics 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:
  • Provide technical leadership with external microbiome collaborators in the field, providing process development expertise and support to advance their therapeutic assets into the clinic
  • Responsible for helping build internal process development and manufacturing capabilities for microbiome therapeutics by evaluating , implementing, and operating critical equipment to support strain processing and culture
  • Assist in the management of Contact Development and Manufacturing Organizations during the clinical development of microbiome assets
  • Lead cross-functional CMC teams, including Formulation and Analytics, to develop integrated strategies to accelerate the clinical development and commercialization of microbiome therapies


Qualifications:


EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education and Experience:

  • Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 15+ years relevant industry experience
  • Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 13+ years relevant industry experience
  • PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 7+ years relevant industry experience
  • Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP’s
  • Sound knowledge of current Good Manufacturing Practices (cGMP)
  • Significant relevant pharmaceutical development experience
  • Significant technical and strategic leadership and accomplishments
  • Experience in working in a multi-disciplinary environment with accountability for informing departmental or functional strategy.
  • Experience leading functional regulatory strategy


Knowledge and Skills:

  • Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems and determine the causes and possible solutions;
  • Teamwork -- Ability to work well on global cross-functional team.
  • Communication Skills -Ability to expresses one’s self clearly and concisely within team; documents issues and/or concerns concisely and comprehensively; adjusts communication style as appropriate for the audience timely and effectively communicates with senior management; technical writing skills to support authorship of internal/external and approval of internal technical documents
  • Organization –Exercises good time management and prioritization skills to balance a number of project and departmental objectives
  • Technical - Recognized specialist in defined scientific area or areas
  • Knowledge Sharing - ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use
  • External Involvement – Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events and communicating new scientific trends . Interacts with external vendors for projects
  • Leadership Skills – Develops and uses knowledge and interpersonal skills to appropriately influence and guide others towards the accomplishment of department/function goals and objectives


TRAVEL REQUIREMENTS:

  • May require approximately 15-20% 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

No Phone Calls or Recruiters Please.

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A little about us:
Takeda fosters an inclusive environment where all employees are empowered to shine.

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