Senior Project Manager (Technical Development)

Pharma Technical Development (PTD) focuses on developing robust manufacturing processes and quality control systems to efficiently transform scientific ideas into products. PTD reliably delivers quality products to patients enrolled in clinical studies around the world. PTD excels by creating an engaging and inclusive environment where everyone can bring their skills and talents to developing innovative medicines.

The Senior Project Manager (Technical Development) is responsible for driving the successful development and launch of clinical candidates.  As a member of this dynamic team, you will collaborate closely with the Technical Development Leader (TDL) and various stakeholders across drug and CMC process development.  You will leverage your project management expertise to ensure efficient planning, execution, and risk mitigation for multiple projects, encompassing large and small molecules, combination products/devices, and new modalities. 

The Opportunity: 

In this role, you will play a pivotal role in helping to prioritize, organize, and complete tasks to increase productivity in a dynamic, fast-paced environment.  Additionally, you will:

• Deliver the project CMC strategy and objectives aligned with the Project Team goals for multiple projects

• Utilize drug/CMC process development knowledge and project management skills to manage TDT(s) and partners/CMOs across various platforms including large and small molecules, combination products/devices, and new modalities

• Establish and maintain integrated project schedules while managing and mitigating risks associated with CMC critical paths

• Ensure adherence to timelines and milestones through proactive risk assessment and driving business processes for TDTs

• Plan and manage TDT meetings effectively, facilitating discussions and driving decision-making to achieve desired outcomes

• Keep stakeholders updated on project status, key risks, and issues, ensuring all project-related information is current in information systems

• Apply agile principles to ensure efficient meetings, focused decisions, and transparent communication

Who You Are:

• You possess a Bachelor’s degree in life sciences or related discipline along with 5+ years of demonstrated drug development and CMC process development project management experience 

• You possess an advanced understanding of project management methodology, business processes, and tools, including process validation, CMC functions, regulatory, quality, and cGMP

• You have experience in a PM capacity where you have led and advocated for digital technology advancement and for driving digital transformation 

• You have strong collaborative and relationship-building skills, demonstrated ability to effectively partner with and influence internal and external stakeholders

• You possess a proven track record of successfully navigating complex organizational dynamics and influencing strategic decisions

• You have demonstrated experience in resource planning and optimization, ensuring project deliverables align with organizational goals and capacities

• You possess demonstrated ability to exercise independent judgment in obtaining results and handling multiple priorities in a fast-paced, ever-changing, team-based environment

• You possess excellent verbal and written communication skills, effectively articulating TDT strategy and deliverables to team members and external business partners

• You are a proactive problem solver and self-motivated to drive key deliverables

Preferred Experience/Certification:

• PMP certification

Relocation benefits are not approved for this posting.  

The expected salary range for this position based on the primary location of California is $117,300 - $217,900.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed in this link.

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