Posted to MedZilla on 3/29/2017


Takeda Pharmaceuticals

US-MA, Process Chemistry Associate Director 1700271-MZ


 
 

OBJECTIVES:
Process chemistry is responsible for the development and execution of robust and cost-effective processes for the manufacture of new small molecule APIs, along with methods for achieving and controlling high standards of purity and quality, throughout the entire development lifecycle.

The successful candidate for an associate director within the process chemistry department will manage his/her staff with accountability for performance and results including: the development and characterization of chemical processes, technical transfer to CMOs, oversight of cGMP manufacture, and representation on CMC teams. As a leader within the process chemistry department, the successful candidate will contribute his/her technical expertise across multiple projects, maintain expertise by benchmarking current industry trends in process chemistry, and drive the optimization of departmental operational procedures. He/she will also be expected to contribute to and drive both line function and cross-functional strategy and lead teams with accountability for performance and results.

ACCOUNTABILITIES:

  • Assure technical deliverables for API projects under personal and team direction (process development work captured in technical reports, tech transfer and cGMP productions, process characterization consistent with QbD principals, and process validation as appropriate)
  • Contributes significantly to develop, drive and set vision and direction of departmental activities, management of resources, time, personnel and financial resources.
  • Develops and manages strategies for process chemistry infrastructure, resources, projects, outsourcing, etc. in conjunction with senior staff.
  • Serves as a technical resource to guide group members in strategic decision making and conducts analysis of technical and conceptual risk; identifies and champions operational processes and mitigation strategies.
  • Monitors industry trends and recommends and implements new technologies and innovations to deliver upon process chemistry goals as appropriate.
  • Develops discipline/departmental plans/initiatives and drives strategy and implementation for process chemistry, creating linkages with strategies of other relevant functions.
  • Manages aspects of department performance, personnel issues, and effective communication within group and with the company as directed by senior staff.
  • Provides technical /departmental leadership by fostering development of skill sets among staff, and providing guidance on project leadership and cross-functional awareness
  • Leads CMC sub teams and/or other cross functional teams
  • Contributes to cross-departmental strategy and identifies topics for initiatives and leads local/global department and cross-department initiatives with accountability for performance and results. Communicates efforts with senior management of other functions as appropriate.

Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Required:

  • Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 15+ years relevant industry experience
  • Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 13+ years relevant industry experience
  • PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 7+ years relevant industry experience
  • Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP s
  • Sound knowledge of current Good Manufacturing Practices (cGMP)
  • Significant relevant pharmaceutical development experience
  • Significant technical and strategic leadership experience with direct accountability for managing a team of direct reports.
  • Experience in working in a multi-disciplinary environment with accountability for informing departmental or functional strategy.
  • Experience leading functional regulatory strategy

Knowledge and Skills:

  • Analytical and Problem Solving Skills - Able to troubleshoot the critical issues or problems and determine causes and possible solutions
  • Teamwork -- Ability to work well on global cross-functional teams; Proven ability to foster a highly efficient team environment.
  • Communication Skills -Ability to expresses one s self clearly and concisely within team; documents issues and/or concerns concisely and comprehensively; adjusts communication style appropriate for the audience; timely and effectively communicates with senior management and direct reports; technical writing skills to support authorship of internal/external and approve internal technical documents
  • Organization Exercises good time management and prioritization skills to balance a number of project and departmental objectives
  • Technical - Relevant expertise across a broad range of disciplines related to drug development
  • 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 and familiarity with financial aspects related to projects including ability to anticipate and manage internal and external resource needs (people, information, technologies, time, and capital)
  • External Involvement Involved in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events. Communicates or applies industry trends. . Advises team members or directly interacts with external vendors for projects
  • Leadership Skills Demonstrated ability to manage up and down the organization;; Ability to use appropriate management strategies to provide direction for the work of team members and support individual development

TRAVEL REQUIREMENTS:

  • May require approximately 15-20% travel.



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