Posted to MedZilla on 3/26/2017


Takeda Pharmaceuticals

US-MA, Scientist, Formulation Development 1602453-MZ


 
 

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.

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

Qualifications

EDUCATION, 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

LINE FUNCTION SPECIFIC QUALIFICATIONS

Protein formulation development experience preferred; Experience with analytical methods used for protein analysis such as HPLC, CE, spectroscopy, and sub-visible particle analysis; Knowledgeable about Design of Experiments and statistical principles for experimental design and data analysis; Exposure to the development of combination products and drug antibody conjugates preferred; Experience leading technology transfer to aseptic drug product manufacturers preferred


TRAVEL REQUIREMENTS:
May require approximately 5-10% travel.



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Schedule
Full-time

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