Technical Service Lead - Sterile Drug Products

Overview: We are seeking a highly experienced and detail-oriented Technical Service Lead to join our Sterile Drug Product Engineering team. The Technical Service Lead will lead and oversee technical operations for a sterile injectable manufacturing facility. This role is responsible for supporting facility start-up activities, CQV execution, technical transfer, process implementation, and commercial product launch readiness. The position will serve as a key technical interface across Engineering, Manufacturing, Quality, Validation, and external vendors, clients, with future responsibility for building and leading a technical services team.

The ideal candidate will have strong hands-on experience with sterile injectable manufacturing processes, including aseptic filling, isolator technology, lyophilization, visual inspection, labeling, and packaging systems for vial, syringe, and cartridge presentations.

Responsibilities

Technical Oversight

• Provide technical leadership for sterile injectable manufacturing processes including vial, syringe, and cartridge filling operations.
• Oversee equipment and process support for formulation, aseptic filling lines, isolators/RABS, lyophilizers, automatic visual inspection, labeling and packaging equipment.
• Support process design, technology transfer, scale-up activities, and process optimization for new product introductions.
• Collaborate between engineering, quality department, vendors and manufacturing teams during equipment commissioning, qualification, and start-up activities.
• Lead technical investigations, troubleshooting efforts, and implementation of corrective/preventive actions related to manufacturing and process performance.
• As member of global engineering team, strongly connecting and involving in DP global engineering projects planning and implementation.

Regulatory Compliance

• Ensure manufacturing processes and technical operations comply with cGMP requirements, FDA, EU GMP Annex 1, and internal quality standards.
• Review and approve technical documentation including protocols, reports, SOPs, batch records, change controls, and deviation investigations.
• Support regulatory inspections, customer audits, and internal audits by serving as a technical subject matter expert.
• Partner with Quality Assurance to maintain validated state and continuous compliance of sterile manufacturing systems.
• Drive contamination control strategy implementation and support aseptic process simulation/media fill activities.

Project Management

• Lead cross-functional technical transfer and product launch activities from development through commercial manufacturing.
• Manage technical deliverables, planning, risk management, and vendor coordination for new equipment and manufacturing initiatives.
• Support continuous improvement, and operational readiness initiatives within the sterile manufacturing facility.
• Work closely with external equipment suppliers, consultants, and contract partners to ensure successful project execution.

Team Leadership

• Build, mentor, and lead a high-performing technical services team as the organization grows.
• Provide technical guidance and coaching to engineers, production technicians, and manufacturing support staff.
• Foster strong cross-functional collaboration with Manufacturing, Quality, Engineering, Supply Chain, and Program Management teams.
• Establish a culture of accountability, continuous improvement, technical excellence, and proactive problem solving.
• Support resource planning, workload prioritization, and talent development to meet business and project objectives.

Qualifications

Required Qualifications:

• Excellent written and verbal communication skills, with attention to detail and clarity.
• 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.

Preferred Qualifications:

• Strong knowledge of current Good Manufacturing Practices (cGMP), regulatory guidelines (FDA, EMA, ICH), and industry standards.
• Experience with sterile filling, lyophilization, automatic visual inspection is a plus.
• Prior experience supporting regulatory inspections and audits.

The anticipated base salary for this opening is $99,000 to $150,000.