Director of Pharmaceutical Production Operations

Job Description

Job Description

Director of Production & Operations (Pharmaceutical)

Location: Middletown, DE
Job Type: Direct Hire/Permanent

We are seeking an experienced Director to provide end-to-end leadership for our client's CDMO drug-product operations which covers all manufacturing and packaging functions. The person should be a customer focused business model with responsible to set strategy, ensure compliance with all regulatory requirements, deliver reliable supply, and drive continuous improvement across people, processes, and technology. This role drives compliance with Good Manufacturing Practices (GMP), regulatory standards (FDA, EMA, ICH), and company policies.

*Facility Start-up: Support facility delivery and operational readiness for new greenfield facilities. Lead collaboratively and energetically across all aspects of operational readiness and startup. Build an organization with the capability, capacity, and culture to achieve high standards in safety, quality, and operational excellence. Develop and implement site systems and processes, drawing on internal expertise and external best practices. Act as the end-user representative during project delivery-providing input on design, commissioning, and startup decisions to ensure alignment with project goals and long-term strategy.
*Operational Planning: Lead the Production operations strategy, capacity plan, and budget (OpEx/CapEx); align with portfolio, S&OP, and launch timelines.
*Operational Leadership: Direct manufacturing operations (manufacturing and packing) to meet safety, quality, and volume goals.
*Strategic Planning: Develop and execute manufacturing strategies, including budget management and capital expenditure projects. Drive OEE, yield, and cycle-time improvements; reduce scrap and unplanned downtime through Lean/Six Sigma and robust maintenance strategies.
*Staff Management: Build and develop high-performing production team with clear goals and metrics. Hire, train, and mentor production teams, fostering a culture of continuous improvement and safety.
*cGMP Compliance: Drive a right first-time mentality. Ensure all production activities adhere strictly to Current Good Manufacturing Practices (cGMP) and regulatory standards. Partner with QA/QC (including Microbiology) on deviations, CAPA effectiveness, change control, APR/PQR, field alerts/complaints. Contribute to/approve CMC filings and support health-authority inspections and responses.
*Performance Metrics (KPIs): Establish governance for right-first-time execution, deviation reduction, and ongoing performance review. Track and trend operational metrics, implementing improvements to boost efficiency and reduce costs.
*Cross-Functional Collaboration: Work with quality assurance, supply chain, and R&D to ensure seamless production scheduling and material
*Tech Transfer & New Product Introduction: Lead technology transfer from development/Technology Operations into commercial manufacturing and packaging operations; confirm equipment fit, process parameters, and control strategy (CPP/CQA/PAR). Approve transfer packages, MBRs/recipes/BOMs, and sampling plans; ensure launch readiness and timeline adherence.
*Validation & Lifecycle Management: Lead validation lifecycle: PPQ strategy/execution, cleaning validation, lyophilize cycle development, and continued process verification (CPV). Sponsor risk assessments (FMEA/HAZOP), alarm/alert action limit management, and rapid, science-based investigations.

Requirements:
*BS/MS in Chemical/Biochemical Engineering, Pharmaceutics, or related field (advanced degree preferred).
*12-15+ years in drug-product manufacturing with 7+ years leading multi-disciplinary teams.
*Demonstrated excellence in leadership, stakeholder influence, and communication across Quality, EHS, Supply Chain, and Regulatory.
*Strong hands-on leadership style
*Proficient in oral & written communication skills
*Demonstrated ability to read, write, and speak English
*Proficiency in Microsoft Office (Excel, Word, Outlook)
*20% travel is required: both domestic and international
*Strong knowledge of regulatory requirements (FDA, EMA, ISO).
*Excellent problem-solving and critical-thinking skills.
*Strong leadership, communication, and project management skills.
*Familiarity with Enterprise Resource Planning (ERP) systems (e.g., JDE, SAP).

***All Qualified Candidates, please apply and contact Sarah Bartel ***
Email resume to: View email address on ziprecruiter.com

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