Posted to MedZilla on 8/18/2019


Takeda Pharmaceuticals

US-MA, Vaccine CMC Program Lead - Technical Development Team R0008373-MZ


 
 

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Job Description

OBJECTIVES:

This role, which can be filled at the Associate Director or Director level, is the CMC Program Lead and single point of contact for a Technical Development Team (TDT).

  • Be an enterprise thinking integrator of the program CMC activities and ensure that fit for purpose CTM is available at each stage of clinical development
  • Work closely with the Global Program Team (GPT) leader to meet the program needs and ensure the functions are executing with agility and rigor
  • Agree on TDT deliverables and ensure full alignment between Functions and the GPT
  • Represent the TDT team and program in Vaccine Operations (VO) and VBU governance forums and on the GPT
  • Establish the CMC development plan in accordance with quality and regulatory expectations.

ACCOUNTABILITIES and RESPONSIBILITIES:

  • Develops and tracks the CMC development plan, which is aligned with the integrated GPT plan, and ensures all program deliverables are met on time.
  • Develops and signs off on a TDT contract of deliverables to the GPT.
  • Tracks TDT program KPIs and presents updates at the Technical Development Review, Stage Gate Review and other forums.
  • Maintains awareness and alignment within Vaccines Operations an all Program issues being presented at GPT and/or the Development Committee (DECO).
  • Applies scientific knowledge and principles to influence the direction of the program. Critically reviews technical and scientific details. Identifies novel solutions to meet critical program needs.
  • Assesses and communicates program risks and provides risk response strategies in a timely manner to appropriate stakeholders and Vaccine Operations management. Maintains risk register and risk mitigation plan
  • Works proactively with Functional Area Leads (e.g. Regulatory Affairs and Quality Assurance) ensuring agility and high performance.
  • Represents the VO at the GPT and other meetings including with external agencies as required.
  • Guides Program-related inputs to the annual budgeting / MRP processes and ensures that all program activities (internal and external) are appropriately planned and budgeted.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelor s degree required in a scientific or technical discipline; advanced level degree (Master s Degree or PhD) in a scientific or technical discipline would be an advantage.
  • Minimum of 10+ years of experience working in a cross functional biologics development group. This is inclusive of experience in at least one of the following areas: Technical Operations, Analytical Development, Drug Product, QA/QC or Regulatory Affairs CMC.

Technical Skills/Competencies:

  • Requires strong background in a technical / scientific discipline. Must have the maturity to utilize scientific and technical knowledge to provide unique solutions for the benefit of the development program.
  • Must demonstrate knowledge of multiple disciplines included in the TDT structure, e.g., bioprocess engineering, analytics, formulation, validation, quality assurance and/or regulatory affairs.
  • Requires extensive knowledge of current Good Manufacturing Practices and other Regulatory requirements related to Vaccine development and manufacturing.

Management Skills/Competencies

  • Requires ability to develop and use knowledge and interpersonal skills to influence and guide internal and external stakeholders towards the accomplishment of program and cross-divisional goals. Must play the role of an integrator
  • Requires ability to identify/solve technical, budgetary, and schedule risks to the program and propose appropriate risk response strategies.
  • Must be an excellent communicator that can distill complex concepts with clarity of thought in a concise and factual manner. Presentations and documents should be easy to understand for people with limited background knowledge.

TRAVEL REQUIREMENTS:

  • 20-40% travel

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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