Sr. Project Manager (CMC)

Sr. Project Manager (CMC)

Summary

Supports Nektar CMC by leveraging experience in the operational and technical execution of drug development, manufacturing, supply chain, and regulatory submission activities. Develops, maintains, and manages integrated project plans and deliverables for CMC development programs. Helps ensure consistent practices throughout all phases of the development life cycle and facilitates information flow among team members, project leaders, senior management, and corporate clients. May have supervisory responsibility. Serves as an in-house project consultant by evaluating needs and vendor requests for proposals. Plans and directs implementation efforts. Applies best practices to the development, initiation, planning, execution, control, and closure of projects. Interacts with cross-functional teams, including but not limited to process development, analytical, research, quality, supply chain, and regulatory departments. This position contributes to and supports the company’s CMC drug development efforts to create high-value therapeutics that address unmet medical needs.

Essential Duties and Responsibilities

• Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
• Exercises independent judgment in methods, techniques and evaluation criteria for obtaining results.
• Creates formal networks involving coordination among groups. May have supervisory responsibility, which includes managing and setting workload priorities, and supporting professional development.
• Networks with senior internal and external personnel in own area of expertise.
• Acts as an advisor to help meet schedules and resolve technical problems.
• Presents project information and schedules.
• Manages a cross-functional project team, including the compilation and flow of information.
• Troubleshoots and resolves project-related issues.
• Interfaces with internal and external bodies to identify project requirements and accomplish project objectives.
• Develop and implement processes and systems to achieve project requirements.
• Routinely communicates and follows up on project status and issues.
• Evaluates resources assigned to the project to help identify resource constraints.
• Develops and distributes agendas, records minutes, and action item follow up for project meetings.
• Reviews and revises project work plans to accommodate changes in business objectives and priorities.
• Will establish and provide appropriate metrics to demonstrate project progress.
• Leads continuous improvement initiatives and develops, manages, and supports related systems.
• Other related responsibilities as needed to support program objectives.

Additional Qualifications & Experience :

• Subject matter expertise in CMC/drug development preferred.
• Certification in Project Management or demonstrated continuing education in Project Management is preferred.
• Prior experience in managing interdisciplinary or cross functional projects is required.
• A working knowledge of drug development is required.
• Proficient computer skills and good working knowledge of Smartsheet, MS Word, Excel, and PowerPoint are required.
• Must be able to demonstrate strong analytical and problem-solving capabilities. Excellent oral and written communication skills are required.
• Must possess and demonstrate strong leadership, influence and organizational skills.

Education or Degree Requirements:

• A minimum of a bachelor’s degree in a scientific discipline or business or related discipline is required.

Minimum professional Experience:

• A minimum of 8 years project management experience in the development of pharmaceutical, medical products or other related industry experience is required.