Manufacturing Manager

DAVRON CV: Candidate 1913263

MANUFACTURING & ASEPTIC PROCESS LEAD | cGMP COMPLIANCE | CLEANROOM OPERATIONS

Core Expertise

• Aseptic filling and formulation leadership in ISO 5–7 cleanrooms, ensuring sterile product integrity.
• cGMP compliance and batch record governance, including review and approval of production documentation.
• Team leadership: managed a 12-person aseptic manufacturing team across shifts to meet throughput targets.
• Process validation and equipment qualification oversight, supporting validation protocols and cleanroom requalification.
• Continuous improvement and safety championing, applying lean principles to boost efficiency and reduce deviations.

Project Background

• Directed daily aseptic manufacturing operations for sterile drug and formulation production.
• Coordinated production schedules, shift assignments, and cross-functional activities to maintain throughput.
• Implemented media fill protocols and supported validation activities to confirm aseptic processes.
• Managed electronic batch record (EBR/MES) and SAP workflows to ensure accurate production traceability.
• Led process improvements simplifying batch record review and accelerating release readiness.

Key Skills

• EBR/MES | SAP | Microsoft Excel, PowerPoint, Word
• Aseptic Techniques | Media Fill | Sterile Filling
• cGMP Compliance | FDA Regulations | ISO 9001 familiarity
• Batch Records Management | Documentation Control
• Process Validation | Equipment Qualification | Cleanroom Requalification
• Lean Manufacturing | Continuous Improvement | Safety Management

Why Interview this Candidate?

Seasoned manufacturing leader with over a decade of hands-on aseptic biotech production and strong cGMP discipline. They combine cleanroom operations, EBR/MES and SAP proficiency, and validation experience to improve throughput, strengthen compliance, and mentor high-performing teams for immediate operational impact.