004V5962 Biopharma Project/Program Manager

KEY RESPONSIBILITIES

• Capital Project Management:
  Lead and manage full lifecycle of capital projects, including planning, budgeting, execution, and closeout, ensuring alignment with site and corporate goals.
• Technical Leadership:
  Oversee engineering activities for sterile fill-finish operations and lyophilization systems, ensuring compliance with cGMP, FDA, and international regulatory standards.
• Process & Equipment Integration:
  Support design and implementation of process and facility modifications to accommodate new products and clients, ensuring smooth technology transfer and process validation.
• Budget & Financial Oversight:
  Develop and maintain accurate project budgets and forecasts; monitor project spend, track variances, and ensure financial accountability for capital expenditures.
• Documentation & Phase Deliverables:
  Ensure adherence to established project documentation, phase gates, and change management processes for technical and operational projects.
• Cross-Functional Collaboration:
  Partner with Manufacturing, Quality, Validation, EHS, and Supply Chain to deliver integrated project outcomes and support site readiness for commercial and clinical operations.
• Operational Transition Support:
  Contribute to the site’s transformation toward a CDMO business model by aligning engineering practices, capacity planning, and infrastructure to client-driven production needs.
• Vendor & Contractor Management:
  Manage external engineering firms, equipment vendors, and contractors to ensure adherence to project scope, quality, safety, and schedule requirements.

QUALIFICATIONS & REQUIREMENTS

• Education:
  Bachelor’s degree in Engineering (Mechanical, Chemical, Industrial, or related discipline). Advanced degree preferred.
• Experience:
  • Minimum 7–10 years of experience in pharmaceutical manufacturing with a focus on sterile fill-finish and lyophilization .
  • Proven track record in capital project management , ideally within a CDMO or CMO environment .
  • Experience handling cytotoxic or high-potent compound manufacturing operations preferred.
• Technical Expertise:
  • Strong understanding of aseptic processing, lyophilization systems, and cleanroom operations.
  • Knowledge of pharmaceutical packaging (bulk naked pack for Japan, full inspection and labeling for U.S. distribution).
  • Familiarity with process utilities and equipment qualification protocols (IQ/OQ/PQ).
• Project & Financial Skills:
  • Demonstrated success in managing multi-million-dollar capital projects.
  • Skilled in budgeting, forecasting, and cost control within complex, regulated environments.
• Soft Skills:
  • Strong leadership and communication skills, with the ability to influence cross-functional teams.
  • Highly organized, detail-oriented, and capable of managing multiple priorities in a dynamic environment.
• Other:
  • Willingness to work onsite at a GMP manufacturing facility.

LOCATION
On-site 5 days/week, Phoenix, AZ

EMPLOYMENT
Full-time or Contractor