Program Manager - R&D

ICU Medical•Austin, TX

About The Position

The Program Manager has overall accountability for programs and projects from concept through launch. The role ensures the Core Team remains on track with the established and approved business plan, and presents program issues, recommendations, and updates. The Program Manager forms high-performing teams to support timely, high-quality execution of assigned programs. The position develops analyses of schedule, resource, and budget information to support scenario and contingency planning, risk assessment, and decision-making. It maintains program schedules, tracks team performance against time, cost, and quality milestones, and integrates cross-functional deliverables such as Integrated Project Plans. The Program Manager drives day-to-day project activities, manages communications and meetings, follows actions and issues through to resolution, and prepares status reports. When needed to meet timelines, the Program Manager also executes program elements as a team member, including coordinating validation activities. Training in equipment and process validation will be provided as required. Most duties are performed in an office environment. The role may also involve travel, including limited global travel, and work in cleanroom or manufacturing environments to support project execution, validation, start-ups, or first-lot executions. Project and 24/7 operational support may require night, weekend, and holiday hours.

Requirements

Bachelor’s degree in Engineering, Physical Sciences, Chemistry, Pharmacy, or a related field.
At least 5 years of experience, including 5 years in the pharmaceutical industry in a program/project management-related capacity.
Experience with product development and/or licensed pharmaceutical product change management processes.
Experience managing program budgets.
Demonstrated expertise leading and managing cross-functional teams in a highly matrixed environment.
Strong written and verbal communication skills, including presentation skills, and advanced technical writing capability.
Expertise in developing risk mitigation strategies.
Basic knowledge of functions relevant to assigned programs.
Demonstrated leadership competencies, including diligence, planning, analysis, and communication.
Fundamental and advanced program management skills.
Advanced knowledge and hands-on experience with MS Office, including Visio and Project.
Must be at least 18 years of age.
Ability to operate standard office equipment with adequate manual dexterity and coordination.
Ability to gown into a controlled manufacturing area and remain there for up to several hours during project execution.
If traveling internationally, ability to sit for extended periods.

Nice To Haves

PMP certification is preferred but not required.
Cross-functional experience in areas such as Development, Quality, Medical, Commercial, Manufacturing Operations, Clinical, or Regulatory is preferred but not required.
Vendor management or interaction experience is a plus.

Responsibilities

Generate analyses of schedule, resource, and budget information to support scenario and contingency planning, risk assessment, and decision-making.
Maintain program schedules and monitor and track team performance metrics against the approved project plan, including time, cost, and quality milestones.
Collect, analyze, integrate, and maintain cross-functional deliverables, including Integrated Project Plans.
Drive day-to-day project team activities to meet milestones and keep functions on track in compliance with Corporate and Site policies and procedures.
Understand critical-path activities and anticipate potential bottlenecks.
Develop and execute communication plans for timely communication among the Core Team, functional management, senior management, and external partners.
Organize and facilitate effective meetings; identify and delegate action items; track actions to resolution; update project plans and deliverables; identify and resolve issues offline, escalating as required.
Prepare periodic program status reports as requested by management.
Execute program elements as a team member when needed to meet timelines, such as coordinating validation activities.
Perform other related duties as assigned or required.