- Manages performance and delivery of goals for a staff of both PhD and non-PhD scientific employees within PTRDL Boston site
- Accountable across multiple projects leveraging expertise to meet deliverables including development of phase appropriate processes and dosage forms and management of CMOs for the delivery of CTM for clinical studies.
- Act as a functional area expert and capable of reviewing and approving work programs
- Has significant responsibility for the technical and operational performance of the department. May act as CMC lead or lead other cross functional teams.
- Works with the regional or global head and the peer department heads from other regions to help define overall direction to PTRDL Boston site.
- Helps the regional head and/or global head to develop and communicate strategic and tactical direction, and to enhance diversity, inclusion and oneness in the function and in the department in terms of organizational management and operation.
- Contributes to overall outsourcing strategy for department and is responsible for assisting/advising direct reports in vendor management.
- Is recognized as subject matter expert internally within Takeda and externally in peer groups and uses reputation to enable successful performance of the department.
- Writes reports, initiates and reviews documentation and guides others in these efforts, particularly for regulatory filings, and prepares and presents comprehensive technical or project reports and formal presentations to a full range of internal/external audiences.
- Responsible for identification and incorporation of industrial trends and for identifying operational process trends as well as defining and championing operational strategies.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Bachelor s+ 20 years, Master s + 12 years, or Ph.D. degree + 8 years significant and relevant pharmaceutical development and manufacturing experience
- Significant technical leadership experience with direct accountability for managing a team of direct reports.
- Develops and uses knowledge and interpersonal skills to influence and guide internal and external stakeholders effectively adapts well to different personalities and manages others in a respectful manner
- Familiarity with production and regulatory requirements for oral solid dosage forms. Experience in oncology and parenteral drug product development a plus.
- 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
- Demonstrated independent thought/creativity in science and success in coordinating and executing research to further corporate goals
- Demonstrated ability to successfully direct multiple scientific endeavours simultaneously
- High-level technical skills, with demonstrated application and creativity
- Excellent communication, collaboration and multitasking skills and ability to work in a team setting
- High degree of scientific discretion/intuition
- Conveys ideas in an experimentally detailed yet scientifically concise manner
- Must be able to work in high potency area utilizing all types of personal protective equipment. Need to lift 25 lbs, work on feet for extended periods
- 10 -25 % of time for travel may be required
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