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)

Summary of the Role

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.

Key Responsibilities

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

Required Experience & Skills

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

Preferred Qualifications

Previous managerial experience directly managing people or teams

Experience supporting facility expansions in a large biotech or pharmaceutical company

Experience with Combination Product Operations

Top 3 Must Have Skills

1. Project management

2. Smartsheet

3. NPI variations and change control

Day-to-Day Responsibilities

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

Basic Qualifications

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