Biopharma Operational Readiness Project Lead

PSC Biotech; Raleigh (NC); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical benefits

401(k) matching

PTO & holidays

Education assistance

Life insurance

Job summary

PSC Biotech is seeking a Senior Project Manager - Operational Readiness to lead biopharma projects in the Raleigh/Durham area. You will shape strategic delivery, drive cross-functional readiness, and ensure regulatory compliance across all project stages.

The role requires 10+ years of project leadership in life sciences and strong knowledge of regulatory guidelines, CQV, and manufacturing operations. This is a full-time position focused on site readiness and operational excellence.

Qualifications

• Need Bachelor's or advanced degree in engineering or related life sciences.
• PMP certification is a plus.
• Minimum 10 years leading biopharma projects.
• Experience with biologics drug substance manufacturing.
• Knowledge of regulatory guidelines and CQV activities.

Responsibilities

• Develop project plans and integrated operational readiness workstreams.
• Maintain integrated schedules and risk registers.
• Identify risks and ensure quality/regulatory compliance.
• Lead meetings, workshops, and execution forums.
• Coordinate across interdependent project activities.
• Communicate status updates to management.
• Align readiness plans with construction, commissioning, qualification.
• Support issue management and risk mitigation across lifecycle.
• Facilitate workshops to improve team alignment and readiness planning.

Skills

Project management

Regulatory compliance

Biopharma manufacturing

Stakeholder management

Cross-functional leadership

Education

Bachelor's or advanced degree in engineering or life sciences

Tools

Trackwise

LIMS

Maximo

MES

Job description

PSC Biotech is seeking a Senior Project Manager - Operational Readiness to lead biopharma projects in the Raleigh/Durham area. You will shape strategic delivery, drive cross-functional readiness, and ensure regulatory compliance across all project stages.

The role requires 10+ years of project leadership in life sciences and strong knowledge of regulatory guidelines, CQV, and manufacturing operations. This is a full-time position focused on site readiness and operational excellence.