Sr. Spclst, Project Management

Job Description

Senior Specialist, External Development & Manufacturing (ExDM) – Program Lead (P3)

Job Description

Our company's Pharmaceutical Sciences and Device Development (PSDD) organization translates molecules to medicines, working from the discovery interface through registration stability manufacturing by designing, developing and scaling-up the formulation, device, and manufacturing process. Driving drug product design from the bench to Good Manufacturing Practice (GMP) manufacturing facilities, our scientists and engineers use cutting edge science to transform drug delivery and manufacturing technology to positively impact patients. The External Development and Manufacturing (ExDM) team within PSDD is focused on executing the company's Research Laboratories drug product and device development sourcing strategy across all phases of small and large molecule research and development operations.

The Senior Specialist, External Development & Manufacturing (ExDM) Program Lead (P3) independently leads external manufacturing activities supporting clinical development. This role serves as the primary ExDM representative on cross-functional teams, integrating technical, operational, and financial workstreams to ensure reliable, compliant, clinical supply delivery. This role requires strong ownership, accountability, and collaboration, with a focus on executional excellence, continuous improvement, and strong external partnerships.

Key Responsibilities

• Lead execution of external manufacturing programs across Contract Manufacturing Organizations (CMOs), including planning, coordination, risk management, and issue resolution.

• Track and manage CMO key performance indicators (KPIs) and metrics to drive performance.

• Represent ExDM on project teams and align external manufacturing strategies with program objectives.

• Manage GMP-related activities such as batch record and specification review, change control, release support, investigations, and material coordination.

• Serve as the primary liaison with external partners, driving performance in quality, delivery, and cost.

• Oversee billing, purchase orders, and financial forecasting for assigned programs, while improving financial workflows and reporting.

• Collaborate across Technical Operations, Quality, Global Clinical Supplies, Procurement, and other partner groups to resolve complex technical and operational challenges.

• Identify and implement process improvements across internal workflows and vendor interfaces.

• Serve as a subject matter expert in selected technical or business areas and contribute to organizational capability building.

• Mentor and support junior team members through coaching, knowledge sharing, and project guidance.

• Use digital tools, analytics, and AI-enabled platforms to improve efficiency, decision-making, and communication.

Education Minimum Requirement:

• B.S. with minimum of 5 years relevant industrial experience, or

• M.S. with 3 years of experience in Chemical Engineering, Pharmaceutical Sciences, or related engineering/scientific discipline.

Required Experience and Skills:

• Relevant experience in clinical manufacturing, supply chain, or external manufacturing management within the pharmaceutical industry

• Working knowledge of GMP operations, batch release, investigations, and quality systems

• Strong project management, problem-solving, and stakeholder management skills

• Ability to work independently and lead effectively in a matrixed environment

Preferred Experience and Skills:

• Experience working with external partners or CMOs

• Advanced degree in a relevant discipline

• Experience leading external manufacturing or development programs

• Demonstrated success driving process improvements and scalable solutions

• Ability to influence across cross-functional teams and external partners

• Experience mentoring junior colleagues

• Digital fluency, including analytics and AI-enabled productivity tools

Required Skills:

Preferred Skills:

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