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.
- 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.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Office work
- Computer use
- Airline travel
- 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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