Posted to MedZilla on 1/20/2018


Takeda Pharmaceuticals

US-MA, Senior Scientist, Analytical CMC 1703268-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 Senior Scientist, Analytical CMC in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Scientist working on the Analytical Development 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
  • Prepares and coordinates completion of technology transfer documentation, CMCC 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
  • Coordinates cross-functional teams and resolutions, with a focus on scientific/technical challenges

POSITION ACCOUNTABILITIES:

  • Develops and leverages strategic understanding of project and CMC priorities to plan/coordinate with cross-functional peers and evaluate impact of decisions across CMCC 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
  • Significant technical responsibility for a project area/technical program within the department and potentially across CMCC (i.e. GCT lead)
  • Represents functional area on GCT project teams by communicating activities from designated functional area to project team
  • 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

LINE FUNCTION SPECIFIC QUALIFICATIONS:

Biologics Analytical Development

  • Biochemical
  • Significant experience with a broad variety of biochemical analytical techniques, including but not necessarily limited to liquid chromatography, gel or capillary electrophoresis, and/or spectroscopic-based 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
Bioassay
  • Significant experience with a broad variety of biological assays, including but not necessarily limited to biological assays, including cell-based assays, ELISAs, flow cytometry, SPR, and/or other assays used to evaluate biological properties and process impurities
  • Able to lead cross-program development activities for multiple technologies
  • Able to conduct troubleshooting for complex technical issues and to lead major characterization studies
  • Strong understanding of cell biology/immunology and of technical and regulatory expectations regarding analytical development and product characterization
  • Serves as SME for more complex methods
  • Defines critical technical or scientific gaps within AD-Bio
  • General lab competencies such as equipment maintenance and compliance activities

EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES 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

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.

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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Schedule

Please visit our website at takedajobs.com

 
 


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