Director Production Operations (Biotech Manufacturing)

TL;DR

Director Production Operations (Biotech Manufacturing): Leading end-to-end CDMO drug-product operations for oral solid dosage and sterile products with an accent on facility start-up, cGMP compliance, and operational readiness. Focus on driving continuous improvement through Lean/Six Sigma, managing tech transfer, and ensuring regulatory alignment with FDA and EMA standards.

Location: On-site in Middletown, DE

Company

A global CDMO providing comprehensive pharmaceutical production operations for drug-product manufacturing.

What you will do

• Lead facility start-up and operational readiness for new greenfield facilities, establishing site systems and processes.
• Direct manufacturing and packaging operations to achieve safety, quality, and volume targets.
• Develop and execute manufacturing strategies, including management of OpEx/CapEx budgets and capital expenditure projects.
• Drive strict cGMP compliance and partner with QA/QC on deviations, CAPA effectiveness, and health-authority inspections.
• Lead technology transfer from development into commercial manufacturing, confirming equipment fit and control strategies.
• Oversee the validation lifecycle, including PPQ strategy, cleaning validation, and continued process verification (CPV).

Requirements

• BS/MS in Chemical/Biochemical Engineering, Pharmaceutics, or a related field (advanced degree preferred).
• 12–15+ years of experience in drug-product manufacturing.
• 7+ years of experience leading multi-disciplinary teams.
• Must be based in or able to work on-site in Middletown, DE.
• Proficiency in oral and written English.
• Strong knowledge of FDA, EMA, and ISO regulatory requirements.

Culture & Benefits

• Leadership role in a high-growth environment with a focus on operational excellence.
• Culture centered on safety, quality, and continuous improvement.
• Opportunity for domestic and international travel (approximately 20%).
• Commitment to diversity and equal opportunity employment.