Technical Manager - Sterile Drug Product

i-Pharm Consulting; Wilmington (DE); On-site; USD 120,000 - 150,000; Full time

Job summary

i-Pharm Consulting seeks a senior manufacturing leader for sterile drug product operations. The role focuses on aseptic processing of vials, prefilled syringes, and cartridges and oversees related formulation, filling, lyophilization, and packaging processes to ensure reliable manufacturing performance.

Responsibilities include leading investigations, CAPAs, technology transfer, process validation, and regulatory readiness in line with FDA and EU GMP Annex 1, while collaborating with

Qualifications

• 8+ years of pharma/biotech manufacturing experience, with sterile injectables.

Responsibilities

• Provide technical leadership for sterile drug product manufacturing operations and aseptic processing.

Skills

Aseptic processing

Sterile filling

Isolators/RABS

Lyophilization

Visual inspection

cGMP knowledge

FDA requirements

EU GMP Annex 1

Process validation

IQ/OQ/PQ

Technology transfer

Quality risk management

Regulatory inspections

Project leadership

Education

Bachelor's/Master's in engineering or life sciences

Job description

• Provide technical leadership for sterile drug product manufacturing operations, including aseptic processing of vials, prefilled syringes, and cartridges.
• Support formulation, aseptic filling, isolator/RABS systems, lyophilization, automated visual inspection, and packaging processes to ensure reliable manufacturing performance.
• Lead process troubleshooting, deviation investigations, root cause analysis, and implementation of CAPAs to improve product quality and operational efficiency.
• Drive technology transfer, scale-up, process validation, and new product introduction activities from development through commercial manufacturing.
• Collaborate with Engineering, Production, Quality, and external suppliers during equipment commissioning, qualification, and start-up activities.
• Ensure manufacturing systems operate in compliance with cGMP, FDA, and EU GMP Annex 1 requirements, maintaining inspection readiness at all times.
• Support contamination control strategies, environmental monitoring programs, and aseptic process simulations (media fills).
• Manage technical project deliverables, equipment implementation activities, and continuous improvement initiatives across the sterile manufacturing facility.
• Develop strong cross-functional partnerships and provide technical guidance to manufacturing and engineering teams.

Requirements:

• Bachelor's or Master's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical discipline.
• 8+ years of experience within pharmaceutical or biotechnology manufacturing, with significant exposure to sterile injectable products.
• Demonstrated expertise in aseptic processing, sterile filling operations, isolators/RABS, lyophilization, and visual inspection technologies.
• Strong knowledge of cGMP regulations, FDA requirements, EU GMP Annex 1, contamination control principles, and quality risk management.
• Experience supporting process validation, equipment qualification (IQ/OQ/PQ), technology transfer, and commercial product launches.
• Proven ability to lead technical investigations, resolve complex manufacturing issues, and implement sustainable process improvements.
• Experience supporting regulatory inspections, customer audits, and quality system compliance activities.
• Previous leadership or supervisory experience within a GMP manufacturing environment is preferred.
• Excellent communication, stakeholder management, and project coordination skills.