Program Manager - R&D

Otsuka ICU Medical LLC; Austin (TX); In loco; USD 120.000 - 150.000; Tempo pieno

Descrizione del lavoro

Otsuka ICU Medical LLC is seeking a Program Manager in Austin to lead programs from concept through launch, ensuring the Core Team stays on track with the approved business plan. You will drive cross-functional collaboration, manage schedules, resources, and budgets, and report progress to management and external partners.

The ideal candidate will have pharma program management experience, strong communication, and the ability to form high-performing teams to deliver timely, high-quality

Competenze

• 5+ years in pharma program/project management.
• Experience in product development or licensed pharma changes.
• Cross-functional experience across Development, Quality, Medical, Manufacturing.
• Experience in managing program budgets and vendor interactions.

Mansioni

• Manage program schedules, timelines, budgets, and resources.
• Lead cross-functional teams to meet milestones.
• Prepare status reports for management.
• Coordinate validation activities and ensure compliance.
• Communicate with Core Team, management and external partners.
• Identify and resolve program issues; escalate when needed.

Conoscenze

Cross-functional leadership

Communication skills

Risk mitigation

Project management

Formazione

Bachelor's Degree in Engineering/Physical Sciences/Pharmacy or related

PMP

Strumenti

MS Office

Visio

Project

Descrizione del lavoro

Job Description

The Program Manager has overall accountability for programs and projects from concept through launch. The Program Manager is responsible to ensure the Core Team is on track following the established and approved business plan. The Program Manager is responsible for presenting issues, recommendations and updates in regard to their programs. The PM has the required skills to form high performing teams that will result in the timely and high-quality execution of the assigned program(s).

• Generates analyses of timeline (schedule), resource, and budget information that facilitates scenario & contingency planning, risk assessment and decision-making.
• Maintains program schedule, monitors and tracks team performance metrics (time, cost and quality milestones) relative to the approved project plan.
• Collects, analyzes, integrates, and maintains cross-functional deliverables (i.e. Integrated Project Plans).
• Drives day-to-day Project Team activities to meet project milestones and keep functions on track in compliance with Corporate and Site policies and procedures. Understands critical path activities and anticipates steps that may be bottlenecks.
• Develops and executes communication plan to ensure effective and timely communication between the Core Team and functional management, senior management, and external partners.
• Organizes and facilitates effective meetings. Identifies and delegates action items, follow-up/track action items to resolution, updates project plans & deliverables, as required, identifies issues and ultimately resolves issues off-line (to ensure effective meetings at all levels), with subsequent escalation as required.
• Prepares periodic program status reports as requested by management.
• As required to meet timelines, executes program elements (e.g. coordinate validation activities) as a team member.
• Validation execution and coordination: will be trained in equipment and process validation as required.
• Perform other related duties as assigned or required.

Position Summary

The Program Manager has overall accountability for programs and projects from concept through launch. The Program Manager is responsible to ensure the Core Team is on track following the established and approved business plan. The Program Manager is responsible for presenting issues, recommendations and updates in regard to their programs. The PM has the required skills to form high performing teams that will result in the timely and high-quality execution of the assigned program(s).

Essential Duties & Responsibilities

• Generates analyses of timeline (schedule), resource, and budget information that facilitates scenario & contingency planning, risk assessment and decision‑making.
• Maintains program schedule, monitors and tracks team performance metrics (time, cost and quality milestones) relative to the approved project plan.
• Collects, analyzes, integrates, and maintains cross-functional deliverables (i.e. Integrated Project Plans).
• Drives day‑to‑day Project Team activities to meet project milestones and keep functions on track in compliance with Corporate and Site policies and procedures. Understands critical path activities and anticipates steps that may be bottlenecks.
• Develops and executes communication plan to ensure effective and timely communication between the Core Team and functional management, senior management, and external partners.
• Organizes and facilitates effective meetings. Identifies and delegates action items, follow‑up/track action items to resolution, updates project plans & deliverables, as required, identifies issues and ultimately resolves issues off‑line (to ensure effective meetings at all levels), with subsequent escalation as required.
• Prepares periodic program status reports as requested by management.
• As required to meet timelines, executes program elements (e.g. coordinate validation activities) as a team member.
• Validation execution and coordination: will be trained in equipment and process validation as required.
• Perform other related duties as assigned or required.

Knowledge, Skills & Qualifications

• Well demonstrated expertise in leading and managing cross-functional teams to achieve objectives in a highly matrixed environment.
• Must have strong written and verbal communication skills (including presentation skills), advanced technical writing capability, and expertise in development of risk mitigation strategies.
• Basic knowledge of functions as related to their particular program assignments is essential. The incumbent should also have demonstrated successful leadership competencies (diligence, planning, analysis, and communication).
• Both fundamental and advanced program management skills are necessary to complete the work including advanced knowledge and hands‑on experience with MS Office, including Visio and Project).

Education And Experience

• Bachelor’s Degree is required: Engineering, Physical Sciences, Chemistry, Pharmacy or related fields.
• PMP, preferred, not required
• 5+ years’ experience, including 5 years’ experience in the Pharma Industry in a program/project management‑related capacity, including product development and/or licensed pharma product change management process experience.
• Cross‑functional experience in different areas such as Development, Quality, Medical, Commercial, Manufacturing Operations, Clinical or Regulatory is preferred but not required. Experience in managing program budgets is required and vendor management / interaction is a plus.

Minimum Qualifications

• Must be at least 18 years of age

Travel Requirements

• Typicalrequires travel 5‑20% of the time

Physical Requirements And Work Environment

• The majority of the duties are performed in an office work environment.
• May be required to travel globally (limited).
• Cleanroom and/or manufacturing environment to support project team executions, validation efforts, start‑ups, or first lot executions.
• Ability to work night, weekend and holiday hours as required by projects and by support needs for a 24/7 operation.
• Must have adequate manual dexterity and coordination to operate standard office equipment. Must be able to gown into a controlled manufacturing area and remain for up several hours during project execution.
• If traveling internationally, must be able to sit for extended periods of time.

About Us

Innovation, Impact, and Purpose.

Find Your Future Here.

We manufacture the critical IV solutions providers count on to deliver consistent, reliable care. Each product we make helps ensure patients receive the therapies they need without disruption.

When you work here, you become part of something bigger—a team dedicated to reliability and innovation. No matter the role, your work directly strengthens the healthcare supply chain and impacts patients nationwide.

We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters.

Join us and help shape the future of IV solutions.

EEO Statement

Otsuka ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at [e-mail]. We are committed to providing equal access and opportunities for all candidates.

Otsuka ICU Medical EEO Policy Statement

Know Your Rights: Workplace Discrimination is Illegal Poster

Otsuka ICU Medical CCPA Notice to Job Applicants