Project Manager - Pharmaceutical
Role: Project Manager
Primary Responsibilities
- Capital Project Oversight: Manage end-to-end delivery of major capital projects, including planning, budgeting, execution, and closure, ensuring alignment with organizational objectives.
- Technical Leadership: Direct engineering activities for sterile manufacturing and lyophilization systems, maintaining compliance with global regulatory standards.
- Process Integration: Support facility and process modifications for new product introductions, ensuring seamless technology transfer and validation.
- Financial Management: Prepare and monitor project budgets, track expenditures, and maintain accountability for capital investments.
- Documentation & Governance: Ensure adherence to project documentation standards, phase-gate reviews, and change control processes.
- Cross-Functional Collaboration: Work closely with Manufacturing, Quality, Validation, EHS, and Supply Chain teams to deliver integrated outcomes.
- Operational Transition: Assist in evolving the site toward a contract development and manufacturing model, aligning infrastructure and capacity with client needs.
- Vendor Coordination: Oversee external partners, including engineering firms and equipment suppliers, to ensure compliance with scope, quality, and timelines.
Qualifications
- Education: Bachelor's degree in Engineering (Mechanical, Chemical, Industrial, or related field); advanced degree preferred.
- Experience:
- 7-10 years in pharmaceutical manufacturing, with expertise in sterile fill-finish and lyophilization.
- Proven success in managing large-scale capital projects, ideally within CDMO/CMO environments.
- Experience with cytotoxic or high-potency compounds is advantageous.
- Technical Skills:
- Deep knowledge of aseptic processing, cleanroom operations, and lyophilization systems.
- Familiarity with packaging standards for global markets and equipment qualification protocols (IQ/OQ/PQ).
- Project & Financial Skills:
- Demonstrated ability to manage multi-million-dollar projects and control costs in regulated settings.
- Soft Skills:
- Strong leadership, communication, and organizational abilities; adept at influencing cross-functional teams.
- Other:
- Preference for candidates based near Phoenix, AZ.
- Must be willing to work onsite in a GMP-compliant facility.
Compensation: Salary range varies based on experience, location, and market factors. Actual pay may differ from the stated range and is subject to future adjustments.
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