Location: Onsite - New Albany, OH

Employment Type: Contingent Worker (Contract, W2)

Contract Length: 6 months (possible extension)

Compensation: $62/$71 per hour (based on experience)

Summary of the Role

Join a large biotech pharmaceutical leader's Quality Assurance team as a Project Manager supporting new product introductions (NPI) and facility expansions at a recently established site. This role drives end-to-end project management and execution for manufacturing process, facility, and equipment changes in a highly regulated, cross-functional environment. You will be onsite in New Albany, OH, ensuring project delivery under tight deadlines and occasional flexible hours during peak periods.

Key Responsibilities

• Lead NPIs, including process, facility, equipment, materials, and training modifications
• Develop and execute detailed project plans to ensure successful NPI implementation
• Manage and execute change control processes throughout project lifecycles
• Oversee manufacturing process modifications and technology implementation from design through qualification
• Coordinate with network partners to shape process and technology strategies that meet clinical and commercial timelines
• Facilitate development and optimization of NPI business processes
• Collaborate with Combination Product Operations, Quality, and Regulatory for change control and audit responses
• Generate, revise, review, execute, and approve technical documents such as procedures, protocols, and specifications
• Ensure design and process transfer requirements align with manufacturing strategies
• Promote a safe work environment by adhering to all safety regulations

Required Experience & Skills

• Minimum 7 years' project management experience in biotech, pharmaceutical, or regulated manufacturing
• Hands-on end-to-end project scheduling and cross-functional coordination
• Strong expertise managing NPIs and supporting facility or process expansions
• Proven experience with Smartsheet for project tracking and collaboration
• Change control generation, execution, and closure
• Excellent written and verbal communication, organizational, and risk mitigation skills
• Ability to motivate, lead, and influence cross-functional teams
• Experience supporting manufacturing, process development, QA, and regulatory compliance

Preferred Qualifications

• 15+ years' relevant project management experience in pharmaceutical/biotech manufacturing
• Previous direct people management or leadership in cross-functional project teams

Top 3 Must Have Skills

1. Program/Project Management (NPI or regulated manufacturing projects)

2. Strong organizational skills

3. Ability to initiate and lead cross-functional teams

4. Hands-on Smartsheet expertise

Day-to-Day Responsibilities

• Lead NPIs and coordinate modifications to process, facilities, and equipment
• Develop and implement execution plans and support manufacturing readiness activities
• Manage change control and support technical documentation requirements
• Collaborate across departments and support audit and regulatory requests
• Occasionally adjust work hours during peak project phases as needed

This posting is for Contingent Worker, not an FTE