Technical Service Lead (Sterile Drug Products)

TL;DR

Technical Service Lead (Sterile Drug Products): Leading technical operations for a sterile injectable manufacturing facility with an accent on facility start-up, CQV execution, and commercial product launch readiness. Focus on managing cross-functional technical interfaces, ensuring cGMP compliance, and building a high-performing technical services team.

Location: On-site in Middletown, DE

Salary: $99,000–$150,000

Company

A global pharmaceutical and biotechnology company providing research and manufacturing services.

What you will do

• Provide technical leadership for sterile injectable manufacturing processes including vial, syringe, and cartridge filling.
• Oversee equipment and process support for formulation, aseptic filling lines, isolators, and lyophilizers.
• Lead cross-functional technical transfer and product launch activities from development through commercial manufacturing.
• Manage technical investigations, troubleshooting, and implementation of corrective/preventive actions.
• Build, mentor, and lead a high-performing technical services team.
• Ensure manufacturing processes comply with cGMP, FDA, and EU GMP Annex 1 standards.

Requirements

• Bachelor’s or Master’s degree in engineering, Life Sciences, or related technical discipline.
• Minimum of 8–10 years of experience in the pharmaceutical or biotechnology industry.
• Preferably at least 3 years in a supervisory or managerial role.
• Deep understanding of cGMP requirements, risk-based approach, and global regulatory expectations.
• Proven experience in startup or expansion of manufacturing facilities is highly preferred.
• Excellent written and verbal communication skills.

Nice to have

• Experience with sterile filling, lyophilization, and automatic visual inspection.
• Prior experience supporting regulatory inspections and audits.

Culture & Benefits

• Opportunity to lead and build a new technical services team.
• Involvement in global engineering projects and strategic planning.
• Equal Opportunity Employer committed to diversity and inclusion.
• Professional development and talent growth opportunities.