CMC Project Manager - Sr. Manager - South San Francisco, CA | Biospace
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CMC Project Manager - Sr. Manager

Theravance Biopharma US, Inc.

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Location:
South San Francisco, CA
Posted Date:
6/9/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
CMC, Project Manager,

Job Description


The CMC Project and Outsourcing Manager works collaboratively with CMC team leaders and CMC teams towards achieving project goals by providing project management expertise. The primary responsibility of this role is to manage the CMC project schedules with a focus on effective planning, coordination of activities, and communication. The objective is to ensure smooth and efficient operational implementation of CMC strategy.

In this role you will manage CMC internal and outsourced activities for specified projects at all development stages, interfacing with relevant functional groups, and with external suppliers as necessary. You will facilitate CMC Team meetings and be responsible for efficient conduct and follow through. You will be expected to use key project management tools to plan and track project deliverables. You will also interface with other project managers to integrate CMC plans with overall plans and ensure planning, coordination and communication to enable timely supply of materials and information of the required quality standard.

Duties and Responsibilities

1.   Planning – Create timelines and utilize planning tools such as decision support models and Gantt charts.  Ensure project plans and objectives are clearly established and communicated.  Ensure that responsibilities are understood, risks are identified, progress is measured and plans are updated and adapted as necessary. Work with other project managers to integrate CMC timelines and deliverables with the overall project plans.
2.   Meeting Facilitation - Organize and conduct CMC team meetings and contract service provider discussions as needed.  Provide concise meeting agendas and minutes in a timely fashion, including key decisions and action items.
3.   Communication – Ensure that management and teams are kept apprised of progress against plans, and changes.  Regularly communicate project status including expectations, opportunities and risks.  Report via written communication as well as presentations, discussions and informal interactions.
4.   Outsourcing – Track and manage development and manufacturing activities at contract manufacturing organizations.
5.   Business Development – Support conduct of CMC due diligence.
6.   Regulatory – Coordinate preparation and review of CMC regulatory filings.
7.   Problem Solving – Identify critical path activities and coordinate with responsible parties to ensure deliverables are achieved. Facilitate resolution to keep project activities on track.

Requirements


•   BS or higher degree in a life sciences, engineering, or equivalent technical experience with 5 or more years CMC project management experience in a pharmaceutical company
•   Proven track record of successfully working in interdisciplinary teams on multiple projects in early to late stage clinical development.
•   Excellent project integration, planning, communication and documentation skills. Familiarity with planning tools.
•   Demonstrated ability to work in teams, to build strong relationships and to lead by influence
•   Very strong written and oral communication skills.
•   High energy level, personal productivity, creativity and commitment.