Program Manager - R&D

Otsuka ICU Medical•Austin, TX

14h

About The Position

The Program Manager has overall accountability for programs and projects from concept through launch, ensuring the Core Team remains on track with the established and approved business plan. The role presents program issues, recommendations, and updates, and forms high-performing teams to deliver assigned programs on time and with high quality. The Program Manager analyzes schedule, resource, and budget information to support scenario and contingency planning, risk assessment, and decision-making. They maintain program schedules, monitor team performance against time, cost, and quality milestones, and integrate cross-functional deliverables such as Integrated Project Plans. The role drives day-to-day project activities, manages communications and meetings, tracks actions and issues through resolution, and prepares periodic status reports. When needed, the Program Manager also executes program elements as a team member, including coordinating validation activities, and receives training in equipment and process validation. Most duties are performed in an office environment, with occasional work in cleanroom or manufacturing settings to support project execution, validation, start-ups, or first-lot activities. The role typically involves travel 5–20% of the time and may require global travel. Project needs may require night, weekend, and holiday work in support of a 24/7 operation.

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.
Advanced technical writing capability and expertise in developing risk mitigation strategies.
Basic knowledge of functions related to assigned programs and demonstrated leadership competencies, including diligence, planning, analysis, and communication.
Fundamental and advanced program management skills, including advanced knowledge and hands-on experience with MS Office, 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 several hours during project execution.
Ability to sit for extended periods when traveling internationally.

Nice To Haves

Project Management Professional (PMP) certification is preferred but not required.
Cross-functional experience in areas such as Development, Quality, Medical, Commercial, Manufacturing Operations, Clinical, or Regulatory.
Vendor management or vendor interaction experience.

Responsibilities

Analyze schedule, resource, and budget information to support scenario and contingency planning, risk assessment, and decision-making.
Maintain the program schedule 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, keep functions on track, and comply 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 meetings; identify and delegate action items; track actions to resolution; update project plans and deliverables; identify and resolve issues offline; and escalate as required.
Prepare periodic program status reports as requested by management.
Execute program elements as a team member when necessary to meet timelines, such as coordinating validation activities.
Coordinate and execute validation activities; receive training in equipment and process validation as required.
Perform other related duties as assigned or required.