Project Manager Senior

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)

Join a big biopharma leader as an onsite Project Manager focused on new product introductions (NPI) and facility expansions. Lead and manage cross-functional teams for biotech/pharmaceutical manufacturing projects, ensuring process changes and new technologies are implemented effectively. Support the Quality Assurance program, oversee project execution plans, and ensure all processes meet regulatory and business requirements. This position requires a strong background in change control, project management, and manufacturing operations within the industry.

• Lead NPIs for process, facility, equipment, materials, and training modifications
• Develop and execute comprehensive project execution plans
• Coordinate and execute NPI activities across cross-functional teams
• Manage change control processes, including generation, implementation, and closeout
• Drive manufacturing process modifications and technology implementation through qualification stages
• Engage with network partners to develop process and technology transfer strategies minimizing risks
• Facilitate development and optimization of NPI business processes
• Collaborate with Quality, Regulatory, and Combination Product Operations for audit response and documentation
• Generate, review, and approve technical documents such as procedures, protocols, and specifications
• Ensure alignment of design/process transfer requirements with manufacturing strategies
• Promote and support a safe working environment compliant with EHS standards

• Minimum 7 years of relevant experience in biotech or pharmaceutical manufacturing (15+ years preferred)
• Proven project management experience leading cross-functional teams
• Hands-on experience with end-to-end project schedules and stakeholder coordination
• Expertise with Smartsheet, NPI variations, and change control processes
• Strong communication, organizational, and risk mitigation skills
• Ability to interact with regulatory agencies and respond to audits
• Expertise with process development, QA/QAL, validation, and manufacturing readiness
• Ability to lead, motivate, and set goals for diverse teams

• Previous managerial experience directly managing people or teams
• Experience supporting facility expansions in a large biotech or pharmaceutical company
• Experience with Combination Product Operations

1. Project management

2. Smartsheet

3. NPI variations and change control

• Lead NPIs and process changes through full project lifecycle
• Develop and track detailed project schedules
• Coordinate closely with Process Development, Capital Projects, and Supply Chain teams
• Generate and manage change controls; ensure efficient implementation and closeout
• Facilitate cross-functional meetings and project updates
• Develop technical documentation and training materials
• Respond to regulatory questions and audits as needed

• Doctorate degree and 3 years of experience
• Masters degree and 5 years of experience
• Bachelors degree and 7 years of experience
• Associates degree and 12 years of experience
• High school diploma / GED and 14 years of experience

This posting is for Contingent Worker, not an FTE