7+ years of project management experience in pharmaceutical, biotech, or sterile compounding environments. Overall experience in the ball park of over 15 years.
Demonstrated experience leading construction or expansion of GMP-regulated manufacturing facilities.
Direct experience with cleanroom builds (ISO 7/8 and higher classification preferred).
Strong knowledge of FDA cGMP regulations and 503B outsourcing facility requirements.
Experience managing modular construction projects preferred
Advanced proficiency with MS Project and/or other project management software.
Proven ability to manage multi-vendor, cross-functional projects with aggressive timelines.
Bachelor’s degree in Engineering, Construction Management, Life Sciences, or related field (PMP certification preferred).
Preferred Experience
Prior experience building or remediating a 503B outsourcing facility.
Experience preparing facilities for FDA inspection.
Familiarity with Charleston, SC permitting and construction environment.
Background in sterile injectable manufacturing.
Key Competencies
Strong leadership and stakeholder management skills
Excellent organizational and documentation practices
Risk-based decision-making approach
Detail-oriented with strong compliance mindset
Ability to work on-site in Charleston, SC for critical phases
Deliverables
Completed modular cleanroom facility delivered on time and within budget.
Fully commissioned and qualified GMP-compliant facility
Inspection-ready documentation package
Successful transition to operational manufacturing
