Posted to MedZilla on 4/25/2017


Takeda Pharmaceuticals

US-MA, Senior Manager, Biologics and New Modalities Development 1700445-MZ


 
 

OBJECTIVES:

Provides project management and leadership skills to support the Biologics and New Modalities Development (BNMD) operations group. Recognized expert in managing the logistical and operational aspects of assigned projects and/or processes. The position requires in-depth interactions with scientists and quality specialists from various departments and external vendors.

ACCOUNTABILITIES:

  • Lead the project management for outsourced global projects with multiple work streams (drug substance and antibody drug conjugate CMOs, etc.) and integrate implications for any external operations opportunities.
  • Act as an operational liaison between BNMD functions and stakeholders, Takeda partners, and contract manufacturing organizations. Effectively engage with key stakeholders (internal and external) to ensure timely implementation of project objectives. Identify interdependencies and connections between departments and ensure integrated end to end visibility and alignment.
  • Work closely with functional staff across all facets of biologics product development including global CMC teams and is responsible for end to end project success: from scoping, developing work plans for successful implementation, risk and change management and budget management.
  • Demonstrate an understanding of company priorities, objectives and project timelines. Define and manage critical path, proactively identify and escalate issues and help resolve them.
  • Maintain detailed global project documentation for knowledge management.
  • Demonstrate strategic thought and resource planning to support multi-geographic programs and personnel.
  • Ensure that BNMD tactical execution and related budget plans and LBEs are developed and maintained and that information is effectively utilized by the BNMD leadership team.
  • Identify issues and obstacles that could impact the timely completion of BNMD deliverables and resolve them with team members and/or the relevant functional management.
  • Identify and communicate opportunities for change; plans for team to meet new challenges.

Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • BS and 10+ years experience or advanced degree and 8+ years of experience
  • Must have exceptional working knowledge of CMC operations relating to research and development and investigational drug manufacturing. Must have direct management experience with external contract manufacturing organizations.
  • Demonstrated excellence in project management and effectively managing multiple projects/priorities.
  • Experience implementing systems and processes for support of cross-functional activities.
  • Must have strong PC experience along with expert in MS Office suite applications.
  • Able to troubleshoot critical issues or problems and resolve routine issues using appropriate information.
  • Ability to work well in a cross functional team environment, build consensus and drive resolution of issues while maintaining positive working relationships across functions.
  • Exceptional oral and written communications skills with the capacity to present effectively to a diverse range of audiences.
  • Exercises exceptional time management skills and is able to successfully manage multiple tasks simultaneously.
  • Demonstrate a high degree of self-awareness, self-motivation, initiative, and attention to detail.

PHYSICAL DEMANDS:
  • Office work
  • Computer use
  • Airline travel
TRAVEL REQUIREMENTS:
  • Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
  • Requires approximately 5-10% travel.


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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, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

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Schedule


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