Posted to MedZilla on 6/20/2019


Takeda Pharmaceuticals

US-MA, Associate Scientific Fellow / Senior Scientist, Analytical Development - Biologics R0005489-MZ


 
 

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Job Description

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 / Senior Scientist, Analytical Development Biologics in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Scientific Fellow / Senior Scientist working on the Analytical Development - Biologics team, you will be empowered to develop and leverage your technical skills to contribute to Takeda's mission and work with cross-functional project teams, and a typical day will include:

POSITION OBJECTIVES:

  • Develops project or significant technical strategy within area of expertise
  • Leverages technical skill(s) as a resource/expert within the department and across division to contribute across multiple projects
  • Prepares and coordinates completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and reports within expertise for review
  • Coordinates transfer of projects as necessary
  • Identifies and plans broader technical objectives (project and scientific related) and initiates processes to meet objectives with input from manager as needed
  • Identifies and recommends vendors as appropriate
  • Directs and manages outsourcing across a product platform as appropriate
  • Coordinates cross-functional teams and resolutions, with a focus on scientific/technical challenges

POSITION ACCOUNTABILITIES:

  • Significant technical responsibility for a project area/technical program within the department and potentially across CMC (i.e. Global CMC Team lead)
  • Represents functional area on GCT project teams by communicating activities from designated functional area to project team
  • Insures effective project management of all plans and projects with area of responsibility, linking all scientific efforts to company, program and functional goals
  • Develops and leverages strategic understanding of project and CMC priorities to plan/coordinate with cross-functional peers and evaluate impact of decisions across CMC and other development functions
  • Contributes significantly to complex/multiple projects or functional areas through leading or influencing others
  • Influences and supports initiatives related to driving scientific and technical improvement within function and potentially cross-functionally
  • Reviews, interprets and communicates data cross functionally within CMC and project teams
  • Coordinates others in creating technical reports including reviewing and editing
  • Conducts analysis of technical and conceptual risk and trends
  • Identifies process trends and defines/champions process strategy or use of novel technologies
  • Recognized as a technical expert and resource within function
  • Identifies topics for initiatives and leads local/global initiatives as directed by senior staff
  • Ensures a productive and development-rich environment; provides training/mentoring for junior staff
  • Defines more complex/novel approaches and methodologies to solving complex technical challenges
  • Proactively identifies vendors and builds relationships to gain access to technologies as needed to deliver on pipeline goals
  • Manages key vendor relationships across multiple projects as appropriate, and proactively affects resolution of issues arising at vendors
  • Initiate and influence project direction outside department

EDUCATION, EXPERIENCE AND SKILLS:

Education and Experience:

  • Bachelors degree in chemistry, biology, pharmacy, or related pharmaceutical science and 11+ years relevant industry experience
  • Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 9+ years relevant industry experience
  • PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 3+ years relevant industry experience
  • Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP s
  • 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
  • Previous experience contributing to regulatory filings

Knowledge and Skills:

  • Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems using appropriate information and, determine causes and possible solutions
  • Teamwork -- Ability to work well on global cross-functional teams
  • 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 audienc; timely and effectively communicates with senior management; technical writing skills to support authorship and approval of internal technical documents
  • Organization Exercises good time management and prioritization skills to balance multiple project and departmental objectives
  • Technical - Subject matter expertise in a specific scientific area or areas. Demonstrated ability to successfully contribute across multiple scientific endeavors
  • 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
  • Resource Management -Project management skills; ability to manage one s time within individual, departmental, and corporate goals and timelines; management of internal external resources (vendors)
  • External Involvement Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events. 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

LINE FUNCTION SPECIFIC QUALIFICATIONS:

  • Significant experience with a broad variety of biochemical analytical techniques, including but not necessarily limited to liquid chromatography, gel or capillary electrophoresis, spectrometry and spectroscopy methods
  • May have significant knowledge in specialized subdisciplines such as protein mass spectrometry or biophysics
  • Able to lead cross-program development activities for multiple methods
  • Able to conduct troubleshooting for complex technical issues and to lead major characterization studies
  • Strong understanding of protein structure/function and of technical and regulatory expectations regarding analytical development and product characterization
  • Serves as a SME for more complex methods
  • Defines critical technical or scientific gaps within AD-Bio
  • General lab competencies such as equipment maintenance and compliance activities

PHYSICAL DEMANDS:

  • Use hands on a regular basis to perform experiments and handle small laboratory equipment
  • Able to lift or move up to 40 pounds in the course of daily work
  • Exposure to hazardous/toxic chemicals and reagents

TRAVEL REQUIREMENTS:

  • May require approximately 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.

No Phone Calls or Recruiters Please.

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Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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